FDA panel gives partial backing for Cephalon's Provigil, but not sleepiness.

Pharma Marketletter, October, 2003

The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has backed approval of two new indications for Cephalon's narcolepsy drug Provigil (modafinil), but split down the middle, four-four, on whether the firm should be able to broadly claim the stimulant improves wakefulness in patients with excessive sleepiness associated with disorders of sleep and wakefulness.

Committee members said West Chester, Pennsylvania-based Cephalon had not proven that Provigil was equally effective in every sleep disorder. Panel chairman Claudia Kawas said she worried that, if Cephalon was awarded broad labeling, patients would be given a pill without getting a full work-up for sleep disorders. "We're talking about treating a symptom without...