Boston, Mass., Friday Oct. 26, 2007 11:00AM Adults with Attention Deficit Hyperactivity Disorder (ADHD) treated with CONCERTA OROS methylphenidate HCl Extended-release Tablets showed significant improvements in ADHD symptom management compared to adults taking placebo, according to study results presented today at a major psychiatric medical meeting.
Pharmacological treatment of children and adolescents with ADHD is clearly established but relatively less is known about the treatment of adults with ADHD, notes the studys medical director, Sally Berry, M.D., PhD., of Johnson & Johnson Pharmaceutical Research and Development, LLC. Were encouraged that the CONCERTA findings presented today -- in which CONCERTA significantly improved ADHD symptom management in adults -- can benefit the growing body of knowledge in this important therapeutic area.
The data presented today are part of a Supplemental New Drug Application (sNDA) submitted in August 2007 to the Food and Drug Administration for use of CONCERTA to treat adults with ADHD. CONCERTA is already approved for the treatment of ADHD in children and adolescents ages six to 17.
About the Study
In the study presented today, efficacy was measured as a change in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score. The results showed that CONCERTA achieved a significantly superior reduction in AISRS total score compared to placebo (p=0.012) (mean change was -10.6 1.09 for the CONCERTA group vs. -6.8 1.06 for the placebo group.
In addition, CONCERTA was significantly superior compared to placebo for the key secondary efficacy variables: change in Clinical Global Impression-Improvement (CGI-I) rating (p=0.008); change in Conners Adult ADHD Rating Scale-Self Report (CAARS-S:S) total score (p=0.029) and change in percent of subjects meeting pre-defined Responder criteria (p=0.009).
In the study, 229 patients with ADHD aged 18-65 years were randomized to receive CONCERTA 36-108 mg/day or placebo, for seven weeks. The final analysis set contained data from 226 patients . Patients in the CONCERTA group received a starting dose of 36 mg/day and the dose was increased in 18 mg increments every seven days (2 days) for up to five weeks until response (AISRS scores decreased by 30% and CGI-I rating of 1 very much or 2 much improved) was achieved or titration to the maximum dose of 108 mg. The dose could be reduced one time during the study for tolerability reasons. The mean final dose was 67.7 mg/day.
Adverse events were reported by 93 (84.5%) of patients in the CONCERTA group compared with 74 (63.8%) in the placebo group. The most commonly reported adverse events with CONCERTA included decreased appetite (25.5%), headache (25.5%), dry mouth (20%), anxiety (16.4%), nausea (12.7%), increased blood pressure (10%), insomnia (9.1%), initial insomnia (7.3%), increased heart rate (7.3%), bruxism (6.4%), irritability (6.4%) and muscle tightness (6.4%). There were no serious treatment emergent adverse events reported and 16 (14.5%) and 6 (5.2%) subjects in the CONCERTA and placebo groups, respectively, discontinued due to adverse events.
Todays data presentation included interim results from a long-term, open-label safety study. A similar dose titration protocol was used as in the double-blind study during the first weeks of the study after which the dose was flexible within the range of 36 to 108 mg. Interim results show that CONCERTA was well tolerated in an adult population with ADHD in a dose range from 36mg to 108 mg per day for up to six months.
|Contact: Tricia Geoghegan|