Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention Deficit Hyperactivity Disorder (ADHD) treatments, lisdexamfetamine dimesylate, methylphenidate transdermal system and the investigational non-stimulant treatment under FDA review, guanfacine extended release, at the American Psychiatric Association (APA) annual meeting to be held May 3rd to 8th in Washington, D.C.
"Shire is committed to the advancement of ADHD research, and we are pleased to be presenting the efficacy and safety results from several studies of our ADHD treatments," said Gwendolyn Niebler, Vice President of Global Medical Affairs at Shire. "We believe the physician community will find the lisdexamfetamine dimesylate, methylphenidate transdermal system and guanfacine extended release study findings to be presented at APA a relevant contribution to the growing body of research on our ADHD treatment options."
A summary of the key scientific presentations is provided below. Information about these data presentations mentioned in this release is embargoed until the respective presentation sessions have taken place at the meeting.
Lisdexamfetamine Dimesylate:
May 7, 2008; 12:00 p.m. ET
Lisdexamfetamine Dimesylate Treatment in Children Diagnosed with ADHD: Parental Impressions and Experiences
APA Poster Presentation # NR6-025
May 8, 2008; 11:00 a.m. ET
Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults with ADHD
APA Oral Presentation Session # 28
Methylphenidate Transdermal System:
May 7, 2008; 12:00 p.m. ET
Long-Term Treatment Effects of the Methylphenidate Transdermal System in Boys and Girls with ADHD
APA Poster Presentation # NR6-018
Guanfacine Extended Release:
May 7, 2008; 12:00 p.m. ET
Guanfacine Extended Release: Duration of Effect in Children and Adolescents Aged 6 to 17 Years With ADHD
APA Poster Presentation # NR6-008
May 7, 2008; 12:00 p.m. ET
Response to Guanfacine Extended Release in Children and Adolescents Aged 6 to 17 Years With ADHD
APA Poster Presentation # NR6-040
About ADHD
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC).
The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders.
ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.
To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
SHIRE PLC
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
Thursday, March 19, 2009
Potential Health Risk To Children From Lead Exposure During House Renovation
Ripping out and tearing down to create a divinely designed home, a la HGTV, is all the rage today - and the economic downturn may be leading more families to renovate rather than relocate. But a new study has found that parents need to be aware that all this interior renovation can put their children's health at risk due to exposure to lead.
The study conducted by researchers at Cincinnati Children's Hospital Medical Center found that interior renovation of older housing is associated with a modest increase in children's blood lead level (BLL) and associated long-term health risks. These findings were presented by co-author Stephen Wilson, M.D., at the Pediatric Academic Society (PAS) annual meeting in Honolulu on May 3.
"Any person working on a home where children reside or visit frequently should know that their renovation work could cause lead hazards for the kids if the home was built before 1978, when the government banned lead-based paint in housing," said Adam Spanier, M.D., Ph.D. M.P.H., the study's lead author and director of the Pediatric Environmental Health and Lead Clinic at Cincinnati Children's Hospital Medical Center.
The study of 249 children, all living in homes built before 1978, found that those who resided in houses where renovations had been done had higher blood lead levels than those in houses where no renovating had been done. Researchers used multivariable analysis to find that the kids who had lived through renovation projects had a 12 percent increase in mean BLL by age 2 compared with other children (p<0.01). The increase in BLL seemed related directly to the renovation work, given that if renovation took place within one month prior to measurement, 2-year-old children had a 1.6 micrograms per deciliter increase in average BLL and if the renovation was more recent (within a month before blood tests were done), compared to an average jump of 0.8 micrograms per deciliter in children whose houses had been renovated two to six months before measurement (p<0.01).
The researchers also noted an association between high lead concentration in the building's existing paint and the child's BLL. Specifically, for every 10 milligram per square centimeter increase in paint lead concentration, there was a 7.5 percent increase in average blood lead levels (p=0.02).
Some research studies have shown that children's BLL below 7.5 is associated with intellectual impairment and affects brain development.
"Toxic agents such as lead could have long-term effects on children's brain development even as early as when they are fetuses," said Dr. Spanier. "If lead poisoning goes undetected and untreated in children, it has the potential to result in a number of neurodevelopmental issues, including ADHD and learning problems."
During renovations, most children are exposed to lead paint dust that is disturbed by the work. If precautions are not taken, this lead paint dust may settle on surfaces and could be spread in the air inside the house through interior ventilation systems. Although the study looked at children between the ages of 6 to 24 months, Dr. Spanier cautioned that all young children, particularly those under 6 years, are considered most at risk.
"There are risks to renovating older homes, but there also are lots of ways parents can reduce the risk of lead exposure to their children," Dr. Spanier said. "It's also more cost effective to avoid the problem than to treat an already exposed child. Preventing exposure is the key."
If parents are unsure about the paint or other lead hazards in their home, Dr. Spanier suggested they should visit the Environmental Protection Agency's website at http://www.epa.gov/lead for more information on local labs that can test lead paint. If there are hazards professional abatement is the best option.
However, if abatement of the lead is not an option, there are a few precautions do-it-yourself rehabbers can take while renovating homes.
* Attach a High Efficiency Particulate Air, or HEPA, vacuum to all power tools and use a HEPA vacuum to clean up the area
* Use heavy plastic to cover doorways, windows, floors, and any furniture that can't be removed from the renovated area and to dispose of all trash and debris
* Block off and shut off air conditioning or heating vents in the work area
* Close windows and doors in or near the work area
* Mist paint before sanding or scraping
* Keep everyone not working in the area out and, if possible, have the children stay at a friend or relatives while the work is being done
* Use personal protective devices (masks, gloves, etc)
* Seek training in lead safe work practices
Also, if parents hire a contractor to do their home renovations, it's important to choose someone who has gone through lead safety training.
If parents who have done renovations are worried about their child's lead levels or are concerned they may have been exposed to lead dust from building renovations, a pediatrician or family practitioner can order a lead test for the child. This will allow them to determine the child's lead level and recommend treatment if needed. Several treatment options available, depending on the blood lead levels detected.
"Not having lead hazards in homes would be the goal, but for now, it is important to know lead's health risks to children and what adults can do to avoid them," said Dr. Spanier.
The study conducted by researchers at Cincinnati Children's Hospital Medical Center found that interior renovation of older housing is associated with a modest increase in children's blood lead level (BLL) and associated long-term health risks. These findings were presented by co-author Stephen Wilson, M.D., at the Pediatric Academic Society (PAS) annual meeting in Honolulu on May 3.
"Any person working on a home where children reside or visit frequently should know that their renovation work could cause lead hazards for the kids if the home was built before 1978, when the government banned lead-based paint in housing," said Adam Spanier, M.D., Ph.D. M.P.H., the study's lead author and director of the Pediatric Environmental Health and Lead Clinic at Cincinnati Children's Hospital Medical Center.
The study of 249 children, all living in homes built before 1978, found that those who resided in houses where renovations had been done had higher blood lead levels than those in houses where no renovating had been done. Researchers used multivariable analysis to find that the kids who had lived through renovation projects had a 12 percent increase in mean BLL by age 2 compared with other children (p<0.01). The increase in BLL seemed related directly to the renovation work, given that if renovation took place within one month prior to measurement, 2-year-old children had a 1.6 micrograms per deciliter increase in average BLL and if the renovation was more recent (within a month before blood tests were done), compared to an average jump of 0.8 micrograms per deciliter in children whose houses had been renovated two to six months before measurement (p<0.01).
The researchers also noted an association between high lead concentration in the building's existing paint and the child's BLL. Specifically, for every 10 milligram per square centimeter increase in paint lead concentration, there was a 7.5 percent increase in average blood lead levels (p=0.02).
Some research studies have shown that children's BLL below 7.5 is associated with intellectual impairment and affects brain development.
"Toxic agents such as lead could have long-term effects on children's brain development even as early as when they are fetuses," said Dr. Spanier. "If lead poisoning goes undetected and untreated in children, it has the potential to result in a number of neurodevelopmental issues, including ADHD and learning problems."
During renovations, most children are exposed to lead paint dust that is disturbed by the work. If precautions are not taken, this lead paint dust may settle on surfaces and could be spread in the air inside the house through interior ventilation systems. Although the study looked at children between the ages of 6 to 24 months, Dr. Spanier cautioned that all young children, particularly those under 6 years, are considered most at risk.
"There are risks to renovating older homes, but there also are lots of ways parents can reduce the risk of lead exposure to their children," Dr. Spanier said. "It's also more cost effective to avoid the problem than to treat an already exposed child. Preventing exposure is the key."
If parents are unsure about the paint or other lead hazards in their home, Dr. Spanier suggested they should visit the Environmental Protection Agency's website at http://www.epa.gov/lead for more information on local labs that can test lead paint. If there are hazards professional abatement is the best option.
However, if abatement of the lead is not an option, there are a few precautions do-it-yourself rehabbers can take while renovating homes.
* Attach a High Efficiency Particulate Air, or HEPA, vacuum to all power tools and use a HEPA vacuum to clean up the area
* Use heavy plastic to cover doorways, windows, floors, and any furniture that can't be removed from the renovated area and to dispose of all trash and debris
* Block off and shut off air conditioning or heating vents in the work area
* Close windows and doors in or near the work area
* Mist paint before sanding or scraping
* Keep everyone not working in the area out and, if possible, have the children stay at a friend or relatives while the work is being done
* Use personal protective devices (masks, gloves, etc)
* Seek training in lead safe work practices
Also, if parents hire a contractor to do their home renovations, it's important to choose someone who has gone through lead safety training.
If parents who have done renovations are worried about their child's lead levels or are concerned they may have been exposed to lead dust from building renovations, a pediatrician or family practitioner can order a lead test for the child. This will allow them to determine the child's lead level and recommend treatment if needed. Several treatment options available, depending on the blood lead levels detected.
"Not having lead hazards in homes would be the goal, but for now, it is important to know lead's health risks to children and what adults can do to avoid them," said Dr. Spanier.
Antipsychotic Prescribing For Children Has Risen Sharply
A research team set out to investigate the epidemiologic features of antibiotic prescribing to patients under the age of 18 by GPs (general practitioners, primary care doctors) in Great Britain. They gathered data from the UK General Practice Research Database, involving 384 participating general practices, to identify how many child/adolescent patients were prescribed at least one antipsychotic drug between the beginning of 1992 to the end of 2005. They calculated age-specific prevalences and incidences of antipsychotic prescribing.
You can read about this in the journal Pediatrics.
The researchers found that:
-- In 1992 there were 0.39 users per 1,000 patient-years
-- In 2005 there were 0.77 users per 1,000 patient-years
-- Prescribing prevalence for 7-12 year-old patients nearly tripped between start 1992 to end 2005, from 0.23 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Atypical antipsychotic prescribing rose 60-fold during the same period, from 0.01 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Typical antipsychotic prescribing fell from 0.44 users per 1,000 patient-years in year 2,000 to 0.18 users per 1,000 patient-years in 2005.
Although incidences for typical and atypical antipsychotics showed trends similar to those of the respective prevalences "the overall incidence (number of new starters) for all antipsychotics was relatively stable between 1992 and 2005, which suggests that patients remain on treatment longer. " the researchers wrote.
The researchers concluded that the overall prevalence of antipsychotics nearly doubled during 1992-2005. The increase in the USA during the same period was much greater. Despite lack of conclusive evidence that atypical antipsychotic drugs are superior to older conventional antipsychotics the prescribing of them has increased. The scientists say more research is needed to find out how efficacious and safe these drugs are for children and adolescents.
According to some US newspapers today (Associated Press) children in the United States are prescribed antipsychotic drugs at approximately six times the rate of UK children. Many report that both US and UK kids are probably being over-prescribed.
Most commonly used medications are for treating ADHD (attention deficit hyperactive disorder) and Autism.
Possible reasons for higher US rates, compared to the UK:
1. Prescription drug advertising to non-health care professionals is not allowed in the UK, while it is in the USA. Perhaps US consumers are more aware of available prescription drugs and influence their doctors' prescribing behavior.
2. The UK has a universal health care system which encourages doctors to keep prescription rates low.
3. UK doctors tend to be more conservative than their American counterparts about prescribing psychiatric drugs (quote from Associated Press, Wayne Ray, Vanderbilt University researcher).
You can read about this in the journal Pediatrics.
The researchers found that:
-- In 1992 there were 0.39 users per 1,000 patient-years
-- In 2005 there were 0.77 users per 1,000 patient-years
-- Prescribing prevalence for 7-12 year-old patients nearly tripped between start 1992 to end 2005, from 0.23 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Atypical antipsychotic prescribing rose 60-fold during the same period, from 0.01 users per 1,000 patient-years to 0.61 users per 1,000 patient-years.
-- Typical antipsychotic prescribing fell from 0.44 users per 1,000 patient-years in year 2,000 to 0.18 users per 1,000 patient-years in 2005.
Although incidences for typical and atypical antipsychotics showed trends similar to those of the respective prevalences "the overall incidence (number of new starters) for all antipsychotics was relatively stable between 1992 and 2005, which suggests that patients remain on treatment longer. " the researchers wrote.
The researchers concluded that the overall prevalence of antipsychotics nearly doubled during 1992-2005. The increase in the USA during the same period was much greater. Despite lack of conclusive evidence that atypical antipsychotic drugs are superior to older conventional antipsychotics the prescribing of them has increased. The scientists say more research is needed to find out how efficacious and safe these drugs are for children and adolescents.
According to some US newspapers today (Associated Press) children in the United States are prescribed antipsychotic drugs at approximately six times the rate of UK children. Many report that both US and UK kids are probably being over-prescribed.
Most commonly used medications are for treating ADHD (attention deficit hyperactive disorder) and Autism.
Possible reasons for higher US rates, compared to the UK:
1. Prescription drug advertising to non-health care professionals is not allowed in the UK, while it is in the USA. Perhaps US consumers are more aware of available prescription drugs and influence their doctors' prescribing behavior.
2. The UK has a universal health care system which encourages doctors to keep prescription rates low.
3. UK doctors tend to be more conservative than their American counterparts about prescribing psychiatric drugs (quote from Associated Press, Wayne Ray, Vanderbilt University researcher).
OROS(R) Methylphenidate In Adults With ADHD: New Insights
Although once considered to be a disorder only seen in children, Attention Deficit Hyperactivity Disorder (ADHD) is now known to be a condition associated with a wide range of functional impairments throughout the lifespan(1). In the US, the overall prevalence of ADHD in adults is estimated to range between 3.4% and 4.4%(2), and between 30 and 70% of children with ADHD continue to exhibit symptoms into adult years(3).
Today at the 161st Annual Meeting of the American Psychiatric Association (APA) there were new insights provided into treatment of adult ADHD with OROS(R) methylphenidate (MPH) HCl Extended-release Tablets. The findings included efficacy and safety sub-analyses from a randomized, double-blind, placebo-controlled, dose-titration trial completed in 2007 and final results from a long-term, open-label safety trial.
"What we're learning more and more is that adult ADHD, while considered the same medical condition as pediatric ADHD, often has a strikingly different patient impact due to what can be a lifetime of functional impairment related to individualized symptoms," noted Lenard Adler, M.D., Director of the Adult ADHD Program at the NYU Langone Medical Center and Associate Professor of Psychiatry, Neurology and Child and Adolescent Psychiatry at the NYU School of Medicine. Dr. Adler* participated as an investigator in the long-term, open-label trial and was the lead investigator of the placebo-controlled dose-titration trial presented in October 2007. In that study, 226 patients with ADHD ages 18-65 were randomized to receive placebo or OROS(R) MPH (36 to 108 mg/day) for seven weeks; results showed significant improvements with OROS(R) MPH in symptom management compared to placebo.
Efficacy Findings from Short-Term, Dose-Titration Trial
In sub-analysis findings from that study presented today, OROS(R) MPH demonstrated efficacy in the study population. Specifically, OROS(R) MPH demonstrated significant efficacy in adults with ADHD across the dose range studied (36 to 108 mg/day) and consistency in symptom evaluation between clinicians (using the Adult ADHD Investigator Symptom Rating Scale [AISRS]) and patients (using the Conners' Adult ADHD Rating Scale-Self Report, Short Version [CAARS-S:S]).
"What's important about these data is that patients and clinicians in this study showed clear agreement on how each viewed the severity of the condition being treated, as well as the patient response to the medication being tested," notes Joseph M. Palumbo, M.D., Franchise Medical Leader in Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD). "What we saw in patients' responses to treatment across the dose range studied suggest that adults with ADHD may benefit from more personalized treatment options."
Safety and Cardiovascular Data
Other findings presented today showed OROS(R) MPH to be well tolerated, with no unexpected cardiovascular effects associated with OROS(R) MPH in the study populations of the short-term dose-titration trial as well as the long-term, open-label trial. Consistent with Food and Drug Administration class labeling for all stimulant ADHD medication, which states that patients with serious cardiovascular illness should generally not be treated with stimulants, patients with a history of serious cardiovascular illness were excluded from both the short-term dose-titration study and the long-term open-label trial. Throughout both trials, heart rate and blood pressure were monitored during the titration period and the dose was reduced if certain cut-off heart rate or blood pressure values were reached. The long-term, open-label trial included an ECG every three months.
Final results from the open-label trial conducted for up to one year showed that in the study population of 550 patients, mean increases in blood pressure (BP) and heart rate (HR) observed with OROS(R) MPH were consistent with those seen in other data from the methylphenidate class. Mean systolic and diastolic blood pressure increased by 2.6 mmHg and 1.9mmHg, respectively and mean heart rate increased by 4.1 beats per minute (bpm).
Overall, cardiovascular-related adverse events occurred in 23.3% of patients and mainly consisted of BP and HR increases. There was no evidence of a treatment effect in any ECG assessment aside from an increase in HR. No deaths, heart attacks or strokes were reported and no unexpected safety findings were noted.
The safety profile of OROS(R) MPH in the long-term, open-label study's dose range of 36 mg to 108 mg per day, was consistent with that seen in shorter-term trials in adults. Adverse events with an incidence greater than 10% included decreased appetite, headache, insomnia, dry mouth, anxiety, upper respiratory tract infection, nausea, increased heart rate and irritability.
Additionally, a cardiovascular sub-analysis from the short-term dose-titration study of OROS(R) MPH versus placebo showed no clinically significant mean changes from baseline in blood pressure, heart rate or ECG parameters. The cardiovascular effects noted in this sub-analysis were consistent with those previously documented in other data from the MPH class.
Data from this sub-analysis showed similar mean changes from baseline in systolic and diastolic BP for OROS(R) MPH and placebo groups. Systolic mean change from baseline was -1.2 mmHg for OROS(R) MPH vs. -0.5 mmHg for placebo; diastolic mean change from baseline was +1.1 mmHg for OROS(R) MPH vs. +0.4 mmHg for placebo. Mean change in pulse from baseline was greater for the OROS(R) MPH group, with +3.6 beats per minute (bpm) vs. -1.6 bpm in placebo. Increased BP was the only cardiovascular adverse event reported in greater than 10% of OROS(R) MPH patients (10% for OROS(R) MPH vs. 5.2% for placebo). BP or HR increase led to down titration in 4.5% (5/110) of OROS(R) MPH patients and 0.9% (1/116) of placebo patients.
The studies were presented and sponsored by J&JPRD, which filed for U.S. approval of OROS(R) MPH for the treatment of adult ADHD last year.
Today at the 161st Annual Meeting of the American Psychiatric Association (APA) there were new insights provided into treatment of adult ADHD with OROS(R) methylphenidate (MPH) HCl Extended-release Tablets. The findings included efficacy and safety sub-analyses from a randomized, double-blind, placebo-controlled, dose-titration trial completed in 2007 and final results from a long-term, open-label safety trial.
"What we're learning more and more is that adult ADHD, while considered the same medical condition as pediatric ADHD, often has a strikingly different patient impact due to what can be a lifetime of functional impairment related to individualized symptoms," noted Lenard Adler, M.D., Director of the Adult ADHD Program at the NYU Langone Medical Center and Associate Professor of Psychiatry, Neurology and Child and Adolescent Psychiatry at the NYU School of Medicine. Dr. Adler* participated as an investigator in the long-term, open-label trial and was the lead investigator of the placebo-controlled dose-titration trial presented in October 2007. In that study, 226 patients with ADHD ages 18-65 were randomized to receive placebo or OROS(R) MPH (36 to 108 mg/day) for seven weeks; results showed significant improvements with OROS(R) MPH in symptom management compared to placebo.
Efficacy Findings from Short-Term, Dose-Titration Trial
In sub-analysis findings from that study presented today, OROS(R) MPH demonstrated efficacy in the study population. Specifically, OROS(R) MPH demonstrated significant efficacy in adults with ADHD across the dose range studied (36 to 108 mg/day) and consistency in symptom evaluation between clinicians (using the Adult ADHD Investigator Symptom Rating Scale [AISRS]) and patients (using the Conners' Adult ADHD Rating Scale-Self Report, Short Version [CAARS-S:S]).
"What's important about these data is that patients and clinicians in this study showed clear agreement on how each viewed the severity of the condition being treated, as well as the patient response to the medication being tested," notes Joseph M. Palumbo, M.D., Franchise Medical Leader in Psychiatry, Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD). "What we saw in patients' responses to treatment across the dose range studied suggest that adults with ADHD may benefit from more personalized treatment options."
Safety and Cardiovascular Data
Other findings presented today showed OROS(R) MPH to be well tolerated, with no unexpected cardiovascular effects associated with OROS(R) MPH in the study populations of the short-term dose-titration trial as well as the long-term, open-label trial. Consistent with Food and Drug Administration class labeling for all stimulant ADHD medication, which states that patients with serious cardiovascular illness should generally not be treated with stimulants, patients with a history of serious cardiovascular illness were excluded from both the short-term dose-titration study and the long-term open-label trial. Throughout both trials, heart rate and blood pressure were monitored during the titration period and the dose was reduced if certain cut-off heart rate or blood pressure values were reached. The long-term, open-label trial included an ECG every three months.
Final results from the open-label trial conducted for up to one year showed that in the study population of 550 patients, mean increases in blood pressure (BP) and heart rate (HR) observed with OROS(R) MPH were consistent with those seen in other data from the methylphenidate class. Mean systolic and diastolic blood pressure increased by 2.6 mmHg and 1.9mmHg, respectively and mean heart rate increased by 4.1 beats per minute (bpm).
Overall, cardiovascular-related adverse events occurred in 23.3% of patients and mainly consisted of BP and HR increases. There was no evidence of a treatment effect in any ECG assessment aside from an increase in HR. No deaths, heart attacks or strokes were reported and no unexpected safety findings were noted.
The safety profile of OROS(R) MPH in the long-term, open-label study's dose range of 36 mg to 108 mg per day, was consistent with that seen in shorter-term trials in adults. Adverse events with an incidence greater than 10% included decreased appetite, headache, insomnia, dry mouth, anxiety, upper respiratory tract infection, nausea, increased heart rate and irritability.
Additionally, a cardiovascular sub-analysis from the short-term dose-titration study of OROS(R) MPH versus placebo showed no clinically significant mean changes from baseline in blood pressure, heart rate or ECG parameters. The cardiovascular effects noted in this sub-analysis were consistent with those previously documented in other data from the MPH class.
Data from this sub-analysis showed similar mean changes from baseline in systolic and diastolic BP for OROS(R) MPH and placebo groups. Systolic mean change from baseline was -1.2 mmHg for OROS(R) MPH vs. -0.5 mmHg for placebo; diastolic mean change from baseline was +1.1 mmHg for OROS(R) MPH vs. +0.4 mmHg for placebo. Mean change in pulse from baseline was greater for the OROS(R) MPH group, with +3.6 beats per minute (bpm) vs. -1.6 bpm in placebo. Increased BP was the only cardiovascular adverse event reported in greater than 10% of OROS(R) MPH patients (10% for OROS(R) MPH vs. 5.2% for placebo). BP or HR increase led to down titration in 4.5% (5/110) of OROS(R) MPH patients and 0.9% (1/116) of placebo patients.
The studies were presented and sponsored by J&JPRD, which filed for U.S. approval of OROS(R) MPH for the treatment of adult ADHD last year.
New Analysis In Boys And Girls Shows The ADHD Patch, DAYTRANA(TM) (methylphenidate Transdermal System), Offered ADHD Symptom Control For 12 Months
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings from a new data analysis that was conducted to examine treatment differences with DAYTRANA(TM) (methylphenidate transdermal system) between boys and girls aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). The findings from the analysis reaffirmed that DAYTRANA has an established safety profile and effectively controlled ADHD symptoms in both boys and girls for the duration of the study. Results from this analysis were presented at a national scientific medical meeting in Washington, D.C.
"This analysis further demonstrates that DAYTRANA has a recognized safety profile and is an effective treatment for ADHD symptoms in both boys and girls with the disorder," said Robert Findling, M.D., investigator of the analysis and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center and Professor of Psychiatry at Case Western Reserve University. "The findings are significant because only a relatively modest amount of work has been done to examine the effects of ADHD treatments by gender. This is an important consideration for parents because not only do they need to recognize that ADHD symptoms present differently in girls than in boys, but also because it is important to understand the role of treatment for both sexes."
According to the U.S. Centers for Disease Control and Prevention (CDC), a national survey conducted in 2003 showed that 11 percent of boys have been diagnosed with ADHD, in contrast to 4.4 percent of girls. Additional studies suggest the prevalence of ADHD in girls is critically underestimated and that many school-aged girls with the disorder are undiagnosed and under treated. This may be due to the fact that girls tend to show less disruptive ADHD symptoms such as inattention (e.g., inability to focus, organize and finish tasks), while boys tend to exhibit disruptive symptoms such as hyperactivity and impulsivity (e.g., restlessness, interrupting, impulsive decisions). In children, ADHD may interfere with paying attention in school, completing homework or making friends. Difficulties experienced by these children may continue into adulthood.
Summary of Analysis Findings
This analysis was conducted using data from an open-label, flexible dose, 12-month extension study in which 326 children received DAYTRANA. Children who enrolled in this study previously participated in other studies in which they received DAYTRANA, osmotic-release oral system (OROS) methylphenidate or placebo as part of the study design. The primary objective of this study was to investigate the long term safety profile of ADHD treatment with DAYTRANA, and the secondary objective examined the efficacy of the medication between genders. This subanalysis was conducted to examine treatment differences between boys and girls receiving DAYTRANA.
Adverse events were reported in a higher percentage of boys than girls in all dose groups; however, they were generally comparable between genders. Further, no clinically significant differences in adverse events were noted between boys and girls. Adverse events were typically mild or moderate and consistent with stimulant treatment. The most common adverse events included decreased appetite, headache, upper respiratory tract infection, cough, fever and decreased weight.
In the study, the efficacy of DAYTRANA was measured using the ADHD Rating Scale (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale and the Parent Global Assessment (PGA) rating scale and measurement results were found to be statistically significant on all scales. In the analysis, boys had a 41 percent change on the ADHD-RS-IV (as calculated from a mean baseline score of 11.6, with a mean change from baseline to endpoint of -4.8) and girls had a 23 percent change on the scale (as calculated from a mean baseline score of 11.3, with a mean change from baseline to endpoint of -2.6). Lower scores on the ADHD-RS-IV reflect an improvement in symptom control.
On the CGI-I scale, clinicians rated 83 percent of boys and girls "improved" or "very much improved" at the end of the study compared to week one. Additionally, the PGA rating scale showed that 78 percent of boys and girls "improved" or "very much improved" at the end of the study compared to week one. The results in both the CGI-I and PGA scale were comparable between boys and girls.
Dr. Findling added, "These positive findings, along with previously presented research, reinforces that the ADHD patch is an important treatment option for children, especially those who may benefit from an ADHD medication that can accommodate their changing daily needs."
DAYTRANA is the first and only non-oral medication for treating ADHD in children aged 6 to 12 years. Parents can adjust the wear time up to 9 hours under the physician's advice to accommodate for their child's varying weekdays, weekend and vacation schedules. DAYTRANA is available in four dosage strengths -- 10 mg, 15 mg, 20 mg and 30 mg -- all designed for once-daily use.
While this study evaluated the safety and effectiveness of DAYTRANA for up to 12 months, DAYTRANA has not been studied versus placebo for longer than 7 weeks. Physicians, who prescribe DAYTRANA for long-term use, should periodically re-evaluate patients to assess the usefulness of DAYTRANA for the individual patient.
"This analysis further demonstrates that DAYTRANA has a recognized safety profile and is an effective treatment for ADHD symptoms in both boys and girls with the disorder," said Robert Findling, M.D., investigator of the analysis and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center and Professor of Psychiatry at Case Western Reserve University. "The findings are significant because only a relatively modest amount of work has been done to examine the effects of ADHD treatments by gender. This is an important consideration for parents because not only do they need to recognize that ADHD symptoms present differently in girls than in boys, but also because it is important to understand the role of treatment for both sexes."
According to the U.S. Centers for Disease Control and Prevention (CDC), a national survey conducted in 2003 showed that 11 percent of boys have been diagnosed with ADHD, in contrast to 4.4 percent of girls. Additional studies suggest the prevalence of ADHD in girls is critically underestimated and that many school-aged girls with the disorder are undiagnosed and under treated. This may be due to the fact that girls tend to show less disruptive ADHD symptoms such as inattention (e.g., inability to focus, organize and finish tasks), while boys tend to exhibit disruptive symptoms such as hyperactivity and impulsivity (e.g., restlessness, interrupting, impulsive decisions). In children, ADHD may interfere with paying attention in school, completing homework or making friends. Difficulties experienced by these children may continue into adulthood.
Summary of Analysis Findings
This analysis was conducted using data from an open-label, flexible dose, 12-month extension study in which 326 children received DAYTRANA. Children who enrolled in this study previously participated in other studies in which they received DAYTRANA, osmotic-release oral system (OROS) methylphenidate or placebo as part of the study design. The primary objective of this study was to investigate the long term safety profile of ADHD treatment with DAYTRANA, and the secondary objective examined the efficacy of the medication between genders. This subanalysis was conducted to examine treatment differences between boys and girls receiving DAYTRANA.
Adverse events were reported in a higher percentage of boys than girls in all dose groups; however, they were generally comparable between genders. Further, no clinically significant differences in adverse events were noted between boys and girls. Adverse events were typically mild or moderate and consistent with stimulant treatment. The most common adverse events included decreased appetite, headache, upper respiratory tract infection, cough, fever and decreased weight.
In the study, the efficacy of DAYTRANA was measured using the ADHD Rating Scale (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale and the Parent Global Assessment (PGA) rating scale and measurement results were found to be statistically significant on all scales. In the analysis, boys had a 41 percent change on the ADHD-RS-IV (as calculated from a mean baseline score of 11.6, with a mean change from baseline to endpoint of -4.8) and girls had a 23 percent change on the scale (as calculated from a mean baseline score of 11.3, with a mean change from baseline to endpoint of -2.6). Lower scores on the ADHD-RS-IV reflect an improvement in symptom control.
On the CGI-I scale, clinicians rated 83 percent of boys and girls "improved" or "very much improved" at the end of the study compared to week one. Additionally, the PGA rating scale showed that 78 percent of boys and girls "improved" or "very much improved" at the end of the study compared to week one. The results in both the CGI-I and PGA scale were comparable between boys and girls.
Dr. Findling added, "These positive findings, along with previously presented research, reinforces that the ADHD patch is an important treatment option for children, especially those who may benefit from an ADHD medication that can accommodate their changing daily needs."
DAYTRANA is the first and only non-oral medication for treating ADHD in children aged 6 to 12 years. Parents can adjust the wear time up to 9 hours under the physician's advice to accommodate for their child's varying weekdays, weekend and vacation schedules. DAYTRANA is available in four dosage strengths -- 10 mg, 15 mg, 20 mg and 30 mg -- all designed for once-daily use.
While this study evaluated the safety and effectiveness of DAYTRANA for up to 12 months, DAYTRANA has not been studied versus placebo for longer than 7 weeks. Physicians, who prescribe DAYTRANA for long-term use, should periodically re-evaluate patients to assess the usefulness of DAYTRANA for the individual patient.
Shire Investigational Nonstimulant INTUNIV Showed Significant Efficacy In Reducing ADHD Symptoms
Shire plc(LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, has presented at a major scientific meeting findings from analyses of pivotal trial results of INTUNIV, a selective alpha-2A-agonist. This compound is an investigational once-daily medication, which is being evaluated for the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The data demonstrated that INTUNIV showed significant efficacy in reducing ADHD symptoms for patients taking the medication when compared to patients taking placebo at all measured time points up to 24 hours postdose.
The U.S. Food and Drug Administration (FDA) issued an approvable letter on June 20, 2007, regarding INTUNIV. Shire is conducting additional clinical work which is designed to enhance the label. Upon approval, INTUNIV will be the first selective alpha-2A receptor agonist indicated for the treatment of ADHD that may provide an important treatment option for patients and physicians.
Summary of Analyses
The pooled analysis evaluated results from these patients on a weight adjusted mg/kg basis from two similarly designed, randomized, double-blind, forced-dose titration, multicenter phase III trials. The primary efficacy measure for both studies was change in the ADHD Rating Scale (ADHD-RS-IV) total score from baseline to endpoint. All patient groups treated with INTUNIV showed significantly greater improvement in ADHD-RS-IV total score from baseline to endpoint than the placebo group (P < .001). The ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment.
The analysis also studied duration of effect using the Conners' Parent Rating Scale-Revised Short Form (CPRS-R), which is a comprehensive scale that used observer and self-report ratings to help assess ADHD and evaluate behavioral issues in children and adolescents. The CPRS-R assessments were completed on specified days at approximately 6 PM (after school and before dinner), 8 PM (dinner through bedtime) and 6 AM (waking time/new dose administration time), which represented 12, 14 and 24 hours after the administration of the dose of INTUNIV, respectively. The data demonstrated significant improvement of ADHD symptoms based on total endpoint CPRS-R scores for all weight adjusted dose groups treated with INTUNIV when compared to placebo for all time periods (at 12 hours, P < = .001; at 14 hours, P < .001; and at 24 hours, P=.003).
A separate analysis of the same phase III studies evaluated the percentage of ADHD patients who responded to weight-adjusted treatment with INTUNIV versus those participants receiving placebo. Using the change in the ADHD-RS-IV total score from baseline to endpoint as the primary efficacy measure, responders were defined as those with a 25 percent reduction in score from baseline to endpoint. Findings from the analysis showed that all groups treated with INTUNIV responded to the medication in a shorter time period than the placebo group (14 days versus 20 days, respectively, P = .001).
In the phase III studies, adverse events (AEs) were reported in 80.7 percent of patients treated with INTUNIV and 71.8 percent of patients treated with placebo. Overall, the AEs were mostly mild to moderate in severity. Adverse reactions that appeared to be dose-related in patients given INTUNIV included upper abdominal pain, constipation, dizziness, dry mouth, hypotension, sedation, and somnolence. Serious AEs reported in these analyses were uncommon and rates were similar between patients treated with INTUNIV and patients treated with placebo (0.6% of the INTUNIV group and 0.7% of placebo group, respectively).
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About INTUNIV
INTUNIV, a once-daily formulation of guanfacine, provides a controlled, steady delivery of drug throughout the day with a delivery system that is designed to minimize the fluctuations between peak and trough concentrations as seen with immediate-release guanfacine. INTUNIV is not a controlled substance and does not appear to have a known mechanism for potential abuse or dependence.
Although other ADHD medications work indirectly in the prefrontal cortex, it has been shown that guanfacine, the active ingredient in INTUNIV, works directly by binding selectively to alpha-2A adrenergic cell receptors located in the prefrontal cortex. The prefrontal cortex is an area of the brain associated with executive functioning, ie, working memory, behavioral inhibition, regulation of attention, distractibility, impulsivity, and frustration tolerance. The selective alpha-2A agonist strengthens working memory and prefrontal cortex neuronal firing. This research supports the use of guanfacine for the treatment of ADHD.
Safety data showed that adverse events reported by participants using INTUNIV were generally mild to moderate in severity, with the most common side effects being sedative in nature. Sedation-related, treatment-emergent adverse events were among the most common but emerged in the first two weeks and were usually transient and mild or moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent) and sedation (13 percent). Small to modest changes in blood pressure, pulse rate, and ECG parameters were observed.
About ADHD
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
SHIRE PLC
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: http://www.shire.com/.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.
Source: MIchelle Park
The U.S. Food and Drug Administration (FDA) issued an approvable letter on June 20, 2007, regarding INTUNIV. Shire is conducting additional clinical work which is designed to enhance the label. Upon approval, INTUNIV will be the first selective alpha-2A receptor agonist indicated for the treatment of ADHD that may provide an important treatment option for patients and physicians.
Summary of Analyses
The pooled analysis evaluated results from these patients on a weight adjusted mg/kg basis from two similarly designed, randomized, double-blind, forced-dose titration, multicenter phase III trials. The primary efficacy measure for both studies was change in the ADHD Rating Scale (ADHD-RS-IV) total score from baseline to endpoint. All patient groups treated with INTUNIV showed significantly greater improvement in ADHD-RS-IV total score from baseline to endpoint than the placebo group (P < .001). The ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment.
The analysis also studied duration of effect using the Conners' Parent Rating Scale-Revised Short Form (CPRS-R), which is a comprehensive scale that used observer and self-report ratings to help assess ADHD and evaluate behavioral issues in children and adolescents. The CPRS-R assessments were completed on specified days at approximately 6 PM (after school and before dinner), 8 PM (dinner through bedtime) and 6 AM (waking time/new dose administration time), which represented 12, 14 and 24 hours after the administration of the dose of INTUNIV, respectively. The data demonstrated significant improvement of ADHD symptoms based on total endpoint CPRS-R scores for all weight adjusted dose groups treated with INTUNIV when compared to placebo for all time periods (at 12 hours, P < = .001; at 14 hours, P < .001; and at 24 hours, P=.003).
A separate analysis of the same phase III studies evaluated the percentage of ADHD patients who responded to weight-adjusted treatment with INTUNIV versus those participants receiving placebo. Using the change in the ADHD-RS-IV total score from baseline to endpoint as the primary efficacy measure, responders were defined as those with a 25 percent reduction in score from baseline to endpoint. Findings from the analysis showed that all groups treated with INTUNIV responded to the medication in a shorter time period than the placebo group (14 days versus 20 days, respectively, P = .001).
In the phase III studies, adverse events (AEs) were reported in 80.7 percent of patients treated with INTUNIV and 71.8 percent of patients treated with placebo. Overall, the AEs were mostly mild to moderate in severity. Adverse reactions that appeared to be dose-related in patients given INTUNIV included upper abdominal pain, constipation, dizziness, dry mouth, hypotension, sedation, and somnolence. Serious AEs reported in these analyses were uncommon and rates were similar between patients treated with INTUNIV and patients treated with placebo (0.6% of the INTUNIV group and 0.7% of placebo group, respectively).
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About INTUNIV
INTUNIV, a once-daily formulation of guanfacine, provides a controlled, steady delivery of drug throughout the day with a delivery system that is designed to minimize the fluctuations between peak and trough concentrations as seen with immediate-release guanfacine. INTUNIV is not a controlled substance and does not appear to have a known mechanism for potential abuse or dependence.
Although other ADHD medications work indirectly in the prefrontal cortex, it has been shown that guanfacine, the active ingredient in INTUNIV, works directly by binding selectively to alpha-2A adrenergic cell receptors located in the prefrontal cortex. The prefrontal cortex is an area of the brain associated with executive functioning, ie, working memory, behavioral inhibition, regulation of attention, distractibility, impulsivity, and frustration tolerance. The selective alpha-2A agonist strengthens working memory and prefrontal cortex neuronal firing. This research supports the use of guanfacine for the treatment of ADHD.
Safety data showed that adverse events reported by participants using INTUNIV were generally mild to moderate in severity, with the most common side effects being sedative in nature. Sedation-related, treatment-emergent adverse events were among the most common but emerged in the first two weeks and were usually transient and mild or moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent) and sedation (13 percent). Small to modest changes in blood pressure, pulse rate, and ECG parameters were observed.
About ADHD
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
SHIRE PLC
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: http://www.shire.com/.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.
Source: MIchelle Park
VYVANSE Demonstrated Significant Improvement In ADHD Symptoms In Adults
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, presented the results of a phase III pivotal study in which VYVANSE demonstrated significant improvements in Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults and met all safety and efficacy endpoints.
"Adults with ADHD often find it challenging to focus and organize during the day. The disorder may impact many aspects of their lives from career to family and personal commitments," said Lenard A. Adler, M.D., lead researcher in this study and director of the Adult ADHD program at the NYU Langone Medical Center, associate professor of psychiatry, neurology and child and adolescent psychiatry at the New York University School of Medicine, as well as author of Scattered Minds: Help and Hope for Adults with ADHD (G. P. Putnam's Sons 2006). "This study demonstrated that VYVANSE significantly improved ADHD symptoms in adults, including inattention, such as the ability to focus, organize and complete tasks, which are essential during an adult day, as well as hyperactivity, such as restlessness, and impulsivity."
This double-blind, placebo-controlled, four-week, forced-dose study in 414 adults aged 18 to 55 years showed that treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) provided a significant reduction in ADHD Rating Scale (ADHD-RS-IV) scores within one week that were observed throughout the full treatment period. At endpoint, VYVANSE demonstrated a significant improvement in ADHD symptoms, based on a 43 percent reduction in ADHD-RS scores. This is the largest placebo-controlled stimulant trial of ADHD in adults conducted to date.
Additional Study Findings
Investigators also measured the efficacy of VYVANSE with the Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking VYVANSE rated "much improved" or "very much improved" was approximately 60 percent across all doses and was significantly greater than placebo.
The most commonly reported adverse events in this study were generally mild to moderate in severity and included decreased appetite, insomnia and dry mouth.
On April 23, 2008, Shire received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in children aged 6 to 12 years on February 23, 2007.
Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.
The study was supported by funding from Shire.
Note
ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association.
The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over time.
About ADHD
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
About VYVANSE
Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.
Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.
Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.
Shire PlC
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
"Adults with ADHD often find it challenging to focus and organize during the day. The disorder may impact many aspects of their lives from career to family and personal commitments," said Lenard A. Adler, M.D., lead researcher in this study and director of the Adult ADHD program at the NYU Langone Medical Center, associate professor of psychiatry, neurology and child and adolescent psychiatry at the New York University School of Medicine, as well as author of Scattered Minds: Help and Hope for Adults with ADHD (G. P. Putnam's Sons 2006). "This study demonstrated that VYVANSE significantly improved ADHD symptoms in adults, including inattention, such as the ability to focus, organize and complete tasks, which are essential during an adult day, as well as hyperactivity, such as restlessness, and impulsivity."
This double-blind, placebo-controlled, four-week, forced-dose study in 414 adults aged 18 to 55 years showed that treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) provided a significant reduction in ADHD Rating Scale (ADHD-RS-IV) scores within one week that were observed throughout the full treatment period. At endpoint, VYVANSE demonstrated a significant improvement in ADHD symptoms, based on a 43 percent reduction in ADHD-RS scores. This is the largest placebo-controlled stimulant trial of ADHD in adults conducted to date.
Additional Study Findings
Investigators also measured the efficacy of VYVANSE with the Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking VYVANSE rated "much improved" or "very much improved" was approximately 60 percent across all doses and was significantly greater than placebo.
The most commonly reported adverse events in this study were generally mild to moderate in severity and included decreased appetite, insomnia and dry mouth.
On April 23, 2008, Shire received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in children aged 6 to 12 years on February 23, 2007.
Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.
The study was supported by funding from Shire.
Note
ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association.
The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over time.
About ADHD
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
About VYVANSE
Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.
Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.
Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.
Shire PlC
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
FDA Approves Strattera(R) For Maintenance Of ADHD In Children And Adolescents
Eli Lilly and Company (NYSE: LLY) announced that the United States Food and Drug Administration (FDA) has approved Strattera(R) (atomoxetine HCI) for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults.
"The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD" said Thomas J. Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School. "This is critical as ADHD may be a life-long disease and effective long-term control of symptoms may mean improved outcomes in children and adolescents."
The safety and efficacy of Strattera in the maintenance of ADHD was demonstrated in one of the largest relapse prevention studies ever conducted in ADHD, which is one of the most common mental health disorders in children and adolescents. (1)
The 18-month trial of about 600 children and adolescents aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD, showed Strattera was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, at the end of the trial, patients taking Strattera had lower relapse rates (2.5 percent) as compared to patients taking placebo (12.2 percent).
Strattera provides uninterrupted relief from ADHD symptoms throughout the day into the evening. This is important since the symptoms of ADHD go beyond the work and school day. ADHD patients can experience frustration, low self-esteem, difficulty with relationships and increased lifestyle risks.
"In the past, our understanding of ADHD treatment was limited to clinical data on short-term use, meaning a few weeks or a couple of months," said A.J. Allen, M.D., Ph.D., Strattera global medical director for Eli Lilly and Company. "For the first time, clinicians have guidance that Strattera is effective for up to a year in patients who respond well to initial treatment."
The long-term, international, multi-center study, which was reviewed by the FDA as part of its decision to grant this approval, employed a treatment discontinuation design (3 months of acute open-label treatment followed by up to 15 months of placebo controlled maintenance treatment) that enabled investigators to test the efficacy of Strattera as maintenance therapy. In the study, 604 patients initially received acute open label treatment with Strattera. After 10-weeks, 69% of patients qualified as responders and were re-randomized to double-blind treatment with either Strattera or placebo for nine months. A second six-month randomization occurred after approximately one year of treatment with 81 patients taking Strattera and 82 patients in the placebo group.
Results of both randomization phases showed that patients treated with Strattera had significantly greater continuous response rates versus patients taking placebo. For child and adolescent ADHD patients with a good initial response to Strattera and who continued to respond well for 1 year, 97.5% maintained response on Strattera vs. 87.8% on placebo (relapse rates 2.5% for Strattera vs. 12.2% for placebo). Additionally, relapse rates for those discontinuing treatment after one year were lower than the relapse rates for patients who discontinued treatment during the 6 months following the open label treatment phase (Strattera, 61/292 [20.9%]; placebo, 46/124 [37.1%]).
Strattera was generally well-tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis). In the study, the mean final dose of Strattera was approximately 1.54 mg/kg/day after 12 months and 18 months treatment. There were no significant differences in standardized height change between groups during the post-randomization period.
About ADHD
ADHD is the most common psychiatric disorder to appear in childhood. If left untreated, ADHD can have long-term effects on a child's emotional well-being and social skills, like making friends or doing well at school or at work.(2) ADHD can also have lifelong consequences, including poor peer relations, poor academic and work performance and increased risk-taking behaviors, such as substance abuse.(3)
About Strattera
It is not known precisely how Strattera reduces ADHD symptoms, but scientists believe it works by blocking or slowing reabsorption of norepinephrine, a chemical in the brain considered important in regulating attention, impulsivity and activity levels. This keeps more norepinephrine at work in the spaces between neurons in the brain. Improved efficiency in the norepinephrine system is associated with improvement in symptoms of ADHD.(4) Since its first approval in the United States in 2002, more than 5 million patients have taken Strattera worldwide. It has been studied in more than 6,000 patients in clinical trials, some for as long as three years.
Important Safety Information for Strattera(R) (atomoxetine HCl)
In some children and teens, Strattera increases the risk of suicidal thoughts. A combined analysis of 12 studies of Strattera showed that in children and teens this risk was 0.4% for those taking Strattera compared to none for those taking a sugar pill. A similar analysis in adults treated with Strattera did not reveal an increased risk of suicidal thoughts. Call your doctor right away if your child has thoughts of suicide or sudden changes in mood or behavior, especially at the beginning of treatment or after a change in dose.
Strattera should not be taken if you or your child: are taking or have taken within the past two weeks a medicine for depression called a monoamine oxidase inhibitor (MAOI); have an eye problem called glaucoma; are allergic to anything in STRATTERA.
Tell your doctor if you or a family member has a history of high or low blood pressure, increased heart rate, heart or blood vessel disease or structural heart defects. When on Strattera, tell your doctor right away if you have chest pain, shortness of breath, or fainting, as these may be signs of heart-related conditions that may be life threatening.
In rare cases, Strattera can cause severe liver problems. Call your doctor right away if you or your child has itching, dark urine, yellow skin/eyes, upper right-side abdominal tenderness, or unexplained "flu-like" symptoms.
Tell the doctor about any family history of or if you or your child: has bipolar illness (manic-depressive illness); or has suicidal thoughts or actions before starting Strattera.
If your child develops new psychological symptoms such as abnormal thoughts/behaviors and/or extreme elevated or irritable moods, while taking Strattera you should report them to your child's doctor right away.
For male patients, call your doctor right away if you or your child experience priapism, a painful or prolonged erection lasting more than 4 hours.
Other rare but serious side effects include: serious allergic reactions including swelling, hives, or other allergic reactions; problems passing urine; and slowing of growth in children. As with all ADHD medications, growth should be monitored during treatment although height and weight data for Strattera measured up to 3 years indicates minimal, if any, long-term effects.
Tell your doctor about all prescription and nonprescription medicines that you or your child takes, including vitamins, and herbal supplements. Do not start any new medicine while taking STRATTERA without talking to your doctor first.
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
In children, the most common side effects were upset stomach, decreased appetite, nausea or vomiting, tiredness, and drowsiness. In adults, the most common side effects were constipation, dry mouth, nausea, decreased appetite, dizziness, problems sleeping, sexual side effects, problems urinating, and menstrual cramps. Most people in clinical studies who experienced side effects were not bothered enough to stop using Strattera. Strattera has not been tested in children under 6 years of age or in geriatric adults.
"The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD" said Thomas J. Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School. "This is critical as ADHD may be a life-long disease and effective long-term control of symptoms may mean improved outcomes in children and adolescents."
The safety and efficacy of Strattera in the maintenance of ADHD was demonstrated in one of the largest relapse prevention studies ever conducted in ADHD, which is one of the most common mental health disorders in children and adolescents. (1)
The 18-month trial of about 600 children and adolescents aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD, showed Strattera was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, at the end of the trial, patients taking Strattera had lower relapse rates (2.5 percent) as compared to patients taking placebo (12.2 percent).
Strattera provides uninterrupted relief from ADHD symptoms throughout the day into the evening. This is important since the symptoms of ADHD go beyond the work and school day. ADHD patients can experience frustration, low self-esteem, difficulty with relationships and increased lifestyle risks.
"In the past, our understanding of ADHD treatment was limited to clinical data on short-term use, meaning a few weeks or a couple of months," said A.J. Allen, M.D., Ph.D., Strattera global medical director for Eli Lilly and Company. "For the first time, clinicians have guidance that Strattera is effective for up to a year in patients who respond well to initial treatment."
The long-term, international, multi-center study, which was reviewed by the FDA as part of its decision to grant this approval, employed a treatment discontinuation design (3 months of acute open-label treatment followed by up to 15 months of placebo controlled maintenance treatment) that enabled investigators to test the efficacy of Strattera as maintenance therapy. In the study, 604 patients initially received acute open label treatment with Strattera. After 10-weeks, 69% of patients qualified as responders and were re-randomized to double-blind treatment with either Strattera or placebo for nine months. A second six-month randomization occurred after approximately one year of treatment with 81 patients taking Strattera and 82 patients in the placebo group.
Results of both randomization phases showed that patients treated with Strattera had significantly greater continuous response rates versus patients taking placebo. For child and adolescent ADHD patients with a good initial response to Strattera and who continued to respond well for 1 year, 97.5% maintained response on Strattera vs. 87.8% on placebo (relapse rates 2.5% for Strattera vs. 12.2% for placebo). Additionally, relapse rates for those discontinuing treatment after one year were lower than the relapse rates for patients who discontinued treatment during the 6 months following the open label treatment phase (Strattera, 61/292 [20.9%]; placebo, 46/124 [37.1%]).
Strattera was generally well-tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis). In the study, the mean final dose of Strattera was approximately 1.54 mg/kg/day after 12 months and 18 months treatment. There were no significant differences in standardized height change between groups during the post-randomization period.
About ADHD
ADHD is the most common psychiatric disorder to appear in childhood. If left untreated, ADHD can have long-term effects on a child's emotional well-being and social skills, like making friends or doing well at school or at work.(2) ADHD can also have lifelong consequences, including poor peer relations, poor academic and work performance and increased risk-taking behaviors, such as substance abuse.(3)
About Strattera
It is not known precisely how Strattera reduces ADHD symptoms, but scientists believe it works by blocking or slowing reabsorption of norepinephrine, a chemical in the brain considered important in regulating attention, impulsivity and activity levels. This keeps more norepinephrine at work in the spaces between neurons in the brain. Improved efficiency in the norepinephrine system is associated with improvement in symptoms of ADHD.(4) Since its first approval in the United States in 2002, more than 5 million patients have taken Strattera worldwide. It has been studied in more than 6,000 patients in clinical trials, some for as long as three years.
Important Safety Information for Strattera(R) (atomoxetine HCl)
In some children and teens, Strattera increases the risk of suicidal thoughts. A combined analysis of 12 studies of Strattera showed that in children and teens this risk was 0.4% for those taking Strattera compared to none for those taking a sugar pill. A similar analysis in adults treated with Strattera did not reveal an increased risk of suicidal thoughts. Call your doctor right away if your child has thoughts of suicide or sudden changes in mood or behavior, especially at the beginning of treatment or after a change in dose.
Strattera should not be taken if you or your child: are taking or have taken within the past two weeks a medicine for depression called a monoamine oxidase inhibitor (MAOI); have an eye problem called glaucoma; are allergic to anything in STRATTERA.
Tell your doctor if you or a family member has a history of high or low blood pressure, increased heart rate, heart or blood vessel disease or structural heart defects. When on Strattera, tell your doctor right away if you have chest pain, shortness of breath, or fainting, as these may be signs of heart-related conditions that may be life threatening.
In rare cases, Strattera can cause severe liver problems. Call your doctor right away if you or your child has itching, dark urine, yellow skin/eyes, upper right-side abdominal tenderness, or unexplained "flu-like" symptoms.
Tell the doctor about any family history of or if you or your child: has bipolar illness (manic-depressive illness); or has suicidal thoughts or actions before starting Strattera.
If your child develops new psychological symptoms such as abnormal thoughts/behaviors and/or extreme elevated or irritable moods, while taking Strattera you should report them to your child's doctor right away.
For male patients, call your doctor right away if you or your child experience priapism, a painful or prolonged erection lasting more than 4 hours.
Other rare but serious side effects include: serious allergic reactions including swelling, hives, or other allergic reactions; problems passing urine; and slowing of growth in children. As with all ADHD medications, growth should be monitored during treatment although height and weight data for Strattera measured up to 3 years indicates minimal, if any, long-term effects.
Tell your doctor about all prescription and nonprescription medicines that you or your child takes, including vitamins, and herbal supplements. Do not start any new medicine while taking STRATTERA without talking to your doctor first.
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
In children, the most common side effects were upset stomach, decreased appetite, nausea or vomiting, tiredness, and drowsiness. In adults, the most common side effects were constipation, dry mouth, nausea, decreased appetite, dizziness, problems sleeping, sexual side effects, problems urinating, and menstrual cramps. Most people in clinical studies who experienced side effects were not bothered enough to stop using Strattera. Strattera has not been tested in children under 6 years of age or in geriatric adults.
AAP And American Heart Association Clarify Statement On ADHD And Electrocardiograms
The American Heart Association released on April 21, 2008, a statement about cardiovascular evaluation and monitoring of children receiving drugs for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). As a result of language in the news release and the statement as published, there have been conflicting interpretations of the recommendations regarding the use of an electrocardiogram (ECG) in assessing children with ADHD who may need treatment with medications. The purpose of this joint advisory of the American Academy of Pediatrics (AAP) and the American Heart Association (AHA) is to clarify the recommendations.
- The scientific statement included a review of data that show children with heart conditions have a higher incidence of ADHD.
- Because certain heart conditions in children may be difficult (even, in some cases, impossible) to detect, the AAP and AHA feel that it is prudent to carefully assess children for heart conditions who need to receive treatment with drugs for ADHD.
- Obtaining a patient and family health history and doing a physical exam focused on cardiovascular disease risk factors (Class I recommendations in the statement) are recommended by the AAP and AHA for assessing patients before treatment with drugs for ADHD.
- Acquiring an ECG is a Class IIa recommendation. This means that it is reasonable for a physician to consider obtaining an ECG as part of the evaluation of children being considered for stimulant drug therapy, but this should be at the physician's judgment, and it is not mandatory to obtain one.
- Treatment of a patient with ADHD should not be withheld because an ECG is not done. The child's physician is the best person to make the assessment about whether there is a need for an ECG.
- Medications that treat ADHD have not been shown to cause heart conditions nor have they been demonstrated to cause sudden cardiac death. However, some of these medications can increase or decrease heart rate and blood pressure. While these side effects are not usually considered dangerous, they should be monitored in children with heart conditions as the physician feels necessary.
An erratum to the statement has been developed to clarify the language and to assure that the intent is clear to all readers. This is available here.
This clarification has been endorsed by the American Academy of Child and Adolescent Psychiatry, the American College of Cardiology, Children and Adults with Attention-Deficit/Hyperactivity Disorder and the National Initiative for Children's Healthcare Quality.
- The scientific statement included a review of data that show children with heart conditions have a higher incidence of ADHD.
- Because certain heart conditions in children may be difficult (even, in some cases, impossible) to detect, the AAP and AHA feel that it is prudent to carefully assess children for heart conditions who need to receive treatment with drugs for ADHD.
- Obtaining a patient and family health history and doing a physical exam focused on cardiovascular disease risk factors (Class I recommendations in the statement) are recommended by the AAP and AHA for assessing patients before treatment with drugs for ADHD.
- Acquiring an ECG is a Class IIa recommendation. This means that it is reasonable for a physician to consider obtaining an ECG as part of the evaluation of children being considered for stimulant drug therapy, but this should be at the physician's judgment, and it is not mandatory to obtain one.
- Treatment of a patient with ADHD should not be withheld because an ECG is not done. The child's physician is the best person to make the assessment about whether there is a need for an ECG.
- Medications that treat ADHD have not been shown to cause heart conditions nor have they been demonstrated to cause sudden cardiac death. However, some of these medications can increase or decrease heart rate and blood pressure. While these side effects are not usually considered dangerous, they should be monitored in children with heart conditions as the physician feels necessary.
An erratum to the statement has been developed to clarify the language and to assure that the intent is clear to all readers. This is available here.
This clarification has been endorsed by the American Academy of Child and Adolescent Psychiatry, the American College of Cardiology, Children and Adults with Attention-Deficit/Hyperactivity Disorder and the National Initiative for Children's Healthcare Quality.
Children's Diet Not The Main Cause Of ADHDChildren's Diet Not The Main Cause Of ADHD
Food may not be the major cause of hyperactivity in children. Genetics, brain function and parental actions such as smoking may be just as important.
A review of scientific evidence found only a minority of children were actually affected by what they eat. A combination of food, genetics and environmental toxins are more likely to be involved, with no single factor to blame.
Foods which might affect behaviour, in particular table sugar were studied. No adverse effects were seen in children who had a sugary drink versus a drink with artificial sweetener. Parents often believe their children's diet is making them hyperactive and think changes in the food provided is the answer to the problem. However changing your child's diet is not likely to settle their over active behaviour.
ADHD (attention deficit/hyperactivity disorder) has a strong genetic link, with half the children born of parents with diagnosed ADHD likely to develop the disorder themselves. Chemical imbalances in the brain are also involved and studies have found that children with the condition have on average 4% smaller brains. Genes may interact with environmental toxins such as alcohol in the womb, lead, and parental smoking to cause later problems with attention span.
Professor David Benton, who specialises in eating behaviour and who carried out the study said 'Parents say after an hour of eating sugary foods that their child is distracted and fidgety, but studies show that this is more what the mother expects to see and not what's really going on'. He added 'the origin of the idea that sugar is responsible for hyperactivity seems to be purely based on the fact that sugar is a source of energy, as are other carbohydrates. Foods like wheat and dairy can often cause food intolerance in children, but this is a completely different reaction of the immune system.'
This review which was carried out at the University of Wales, Swansea is published in the May issue of the journal Critical Reviews in Food Science and Nutrition. It comes at a time when the Food Standards Agency is looking at other causes of hyperactivity in children with a call to remove certain additives in foods.
Up to 9% of children in the U.K. have been diagnosed with ADHD. Problems are usually seen at around 4 years of age when the child may become easily distracted, fidgety, and impulsive over a long period of time.
A review of scientific evidence found only a minority of children were actually affected by what they eat. A combination of food, genetics and environmental toxins are more likely to be involved, with no single factor to blame.
Foods which might affect behaviour, in particular table sugar were studied. No adverse effects were seen in children who had a sugary drink versus a drink with artificial sweetener. Parents often believe their children's diet is making them hyperactive and think changes in the food provided is the answer to the problem. However changing your child's diet is not likely to settle their over active behaviour.
ADHD (attention deficit/hyperactivity disorder) has a strong genetic link, with half the children born of parents with diagnosed ADHD likely to develop the disorder themselves. Chemical imbalances in the brain are also involved and studies have found that children with the condition have on average 4% smaller brains. Genes may interact with environmental toxins such as alcohol in the womb, lead, and parental smoking to cause later problems with attention span.
Professor David Benton, who specialises in eating behaviour and who carried out the study said 'Parents say after an hour of eating sugary foods that their child is distracted and fidgety, but studies show that this is more what the mother expects to see and not what's really going on'. He added 'the origin of the idea that sugar is responsible for hyperactivity seems to be purely based on the fact that sugar is a source of energy, as are other carbohydrates. Foods like wheat and dairy can often cause food intolerance in children, but this is a completely different reaction of the immune system.'
This review which was carried out at the University of Wales, Swansea is published in the May issue of the journal Critical Reviews in Food Science and Nutrition. It comes at a time when the Food Standards Agency is looking at other causes of hyperactivity in children with a call to remove certain additives in foods.
Up to 9% of children in the U.K. have been diagnosed with ADHD. Problems are usually seen at around 4 years of age when the child may become easily distracted, fidgety, and impulsive over a long period of time.
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