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
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