The FDA's Peripheral and Central Nervous System Drugs Advisory Committee Thursday is expected to lean in favor of Cephalon Inc.'s request to expand Provigil's label to include the treatment of excessive sleepiness associated with disorders of sleep and wakefulness.
Provigil (modafinil) currently is approved to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Cephalon, of West Chester, Pa., submitted to the FDA a supplemental new drug application containing three newly conducted randomized trials to support its bid for broader label.
In an unusual move on Wednesday, the FDA released to the public a nine-page memorandum explaining that it had not completed its briefing document, a thick drug review package normally sent in advance to panel members. The memorandum was sent to panel members Sept. 8.
Signed by Russell Katz, director of the division of neuropharmacological drug products, the memorandum said, "Unfortunately, the agency reviews of the application are not completed; therefore, we cannot forward you our independent analyses of the data. However, we have reviewed the sponsor's description of the controlled-trial data, and are in general agreement with the results of their analysis."
Bill Tanner, managing director with Leerink Swann & Co. in Boston, released a research note saying the company's consultants believe the supplemental application will receive a positive panel review. Tanner's note said Provigil, often used off label in a number of indications including fatigue, has experienced attractive revenue growth over the last three years. Sales have reached $72 million, $150 million and $196 million for 2000, 2001 and 2002, respectively.
The FDA is not bound by advice or recommendations issued by its panels.
Cephalon's stock (NASDAQ:CEPH) fell 64 cents Wednesday to close at $45.67.