Shire/Noven Daytrana data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Shire and Noven's Phase II study of ADHD methylphenidate transdermal system Daytrana, presented at the American Academy of Child & Adolescent Psychiatry in Toronto Oct. 20 & 21, shows a statistically significant improvement over placebo after 12 hours (p<0.001). Similar results to the 79-patient Phase II "classroom study" were seen in the 270-patient Phase III "naturalistic" trial measuring "overall symptoms," also reported at AACAP. The trials are included in Shire's June 28 resubmission for use in children ages six to 12 (1Pharmaceutical Approvals Monthly August 2005, In Brief). A Dec. 2 review is planned by FDA's Psychopharmacologic Drugs Advisory Committee...