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New Study of Concerta(R) Showed Significant Improvement of ADHD Symptom Management in Adults Compared to Placebo
Date:10/26/2007

eeting pre-defined Responder criteria (p=0.009).

In the study, 229 patients with ADHD aged 18-65 years were randomized to receive CONCERTA(R) 36-108 mg/day or placebo, for seven weeks. The final analysis set contained data from 226 patients(a). Patients in the CONCERTA(R) 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(R) group compared with 74 (63.8%) in the placebo group. The most commonly reported adverse events with CONCERTA(R) 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(R) and placebo groups, respectively, discontinued due to adverse events.

Today's 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(R) 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.

About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable neuropsychiatric condition, which includes inattention, hyperactivity and impulsivity. According to the National Institut
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SOURCE McNeil Pediatrics
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