Washington Editor

Cephalon Inc. received FDA clearance to expand the Provigil label to include use in improving wakefulness in people with excessive sleepiness associated with shift-work sleep disorder and in patients with obstructive sleep apnea.

The company expects to launch the new indications during the first quarter of 2004.

"We look forward to finalizing the process and receiving FDA approval," Paul Blake, Cephalon's senior vice president of clinical research and regulatory affairs, said in a prepared statement. "We expect precise labeling language to be decided by year end, which keeps us on track to launch the new indications to a broader group of physicians with our expanded sales force early next year."

Provigil (modafinil) was first approved in 1998 in the U.S. as an orphan drug for patients with narcolepsy.

According to the company, Provigil benefits patients through its ability to promote daytime wakefulness without affecting nighttime sleep. Indeed, that's why it has been prescribed off label for many years.

Officials at West Chester, Pa.-based Cephalon, though, are quick to point out that they have not advertised or sold Provigil as a treatment for anything other than excessive daytime sleepiness associated with narcolepsy.

Of the label expansion, Sheryl Williams, Cephalon's senior director of product communication, told BioWorld Today the company expects sales to increase.

"We would expect them to grow because now we have the ability to market the drug for a broader indication," she said.

The company likely will provide guidance on its third-quarter conference call in the next few weeks, Williams said.

Previous reports have indicated that 80 percent of Provigil's sales are off label, and with FDA approval of the expanded label, Cephalon could hope for blockbuster status. The company loses its U.S. orphan status for the drug in 2006, and the patent expires in 2014.

The FDA's Peripheral and Central Nervous System Drugs Advisory committee in September unanimously agreed that Provigil is effective in treating excessive sleepiness associated with sleep apnea. And in a 6-2 vote, the panel said the company's data supported the claim that Provigil is effective in the treatment of excessive sleepiness in patients with shift-worker sleep disorder. In a 4-4 vote, the panel said Cephalon had proved Provigil's effectiveness in treating excessive sleepiness associated with "disorders of sleep and wakefulness." (See BioWorld Today, Sept. 26, 2003.)

The drug is sold in 20 other countries for various sleep disorders.

Cephalon's stock (NASDAQ:CEPH) rose $2.18 Tuesday to close at $47.73.