An FDA advisory panel has voted Friday to recommend that Noven Pharmaceuticals’ patch version of a popular drug to treat attention-deficit hyperactivity disorder in children receive market approval. The advisory committee recommended that the removable patch, called Daytrana, be given the green light by the FDA. Although the agency is not bound to panel decisions, it generally follows them. “We are pleased that the committee’s vote was supportive of the efficacy and safety of the product,” Robert C. Strauss, Noven’s president, chief executive and chairman, said in a statement. The move comes one day after the FDA released documents showing that its lead reviewer on the drug’s application, Dr. Robert Levin, had determined the patch should not be put on the market. News of Levin’s negative opinion drove down Noven shares by almost 20% Thursday. Shares were halted all day Friday, pending the outcome of the meeting. Noven (NOVN) has been seeking to have the Daytrana patch approved since 2003. Levin later went on to reverse his opinion while testifying before the advisory panel on Friday, stating he felt the product was worthy of being approved, according to local reports. In his written review, posted on the agency’s Web site Thursday, Levin said that he was concerned that the patch, which elutes the drug methylphenidate, triggered more side effects than pill versions of the drug already out on the market. Methylphenidate is a stimulant that can cause insomnia, anorexia and weight loss, especially in higher doses. The drug has been marketed for years in pill form under such brand names as Ritalin, Methylin and Concerta. Noven first applied to have Daytrana approved in 2003, with a wear time of 12 hours. The FDA rejected that application, stating the patch generated too many side effects, and suggested the company cut down the wear time, according to the documents. Noven resubmitted its application for Daytrana with a wear time of 9 hours in June 2005. After reviewing additional studies submitted by the company, Levin determined the drug still generated too many side effects, according to his written report. Noven has granted the worldwide marketing rights to Daytrana to Shire Pharmaceuticals Group (SHPGY), which also markets the popular ADHD drug Adderall.
