FDA panel reversal: now backs Shire/Noven ADHD patch
An FDA panel last Friday supported an experimental skin patch for treating pediatric attention deficit hyperactivity disorder (ADHD) but discouraged its use as a first-line therapy, Dow Jones Newswires reported.
The panel said that Shire and Noven Pharmaceuticals' proposed Daytrana skin patch should contain a strong recommendation to physicians to try oral therapies first until more information is known about skin reactions.
The FDA is expected to make a decision on whether to approve the patch by year's end.
FDA medical reviewer Robert Levin had recommended that the agency reject the patch, due to concerns about weight loss and insomnia. But on Friday, in a presentation to the independent panel, Levin said the patch was worthy of approval, according to the Dow Jones report. Levin said he had obtained information suggesting most side effects of the patch were similar to those seen with some oral ADHD drugs.
The patch contains methylpheni-date, also the main component in Novartis' Ritalin.
The FDA rejected the product in 2003. To address agency concerns, Shire and Noven submitted an application this year with more information and proposing to have children wear it for nine hours instead of 12.