MEETINGS PLANNED TO DISCUSS ADHD DRUG SAFETY ISSUES

The FDA will convene a pair of advisory committee meetings in March to discuss safety issues associated with attention-deficit/hyperactivity disorder (ADHD) drugs, including reported neuropsychiatric and cardiovascular risks.

On March 22, the agency's Pediatric Advisory Committee will continue a prior committee's discussion of adverse events for the class of methylphenidate products used to treat ADHD. The panel will discuss neuropsychiatric adverse events possibly related to other approved ADHD drugs, the FDA said. The presentations will focus on neuropsychiatric adverse event reports and clinical trial data on approved products. The committee also will receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD drugs, the agency said.

On March 23, the Psychopharmacologic Drugs Advisory Committee will take up Cephalon's new drug application (NDA) for an ADHD indication to Provigil (modafinil), which currently is approved for narcolepsy. Cephalon plans to market the proposed ADHD treatment under the name Sparlon (modafinil).

The FDA issued an approvable letter to Cephalon's NDA for Sparlon on Oct. 20, 2005. Cephalon said it does not expect final action on its application until after the committee meetings. The company now expects to launch Sparlon during the second quarter of 2006, Cephalon said. Provigil was Cephalon's top-selling drug in 2004, generating sales of $439.7 million.

The March advisory committee meetings on ADHD will follow a Feb. 9-10 meeting of the agency's Drug Safety and Risk Management Advisory Committee, which will discuss clinical approaches to study potential cardiovascular risks associated ADHD drugs.