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FDA Issues Approvable Letter to Broaden Provigil (Modafinil) Label
WEST CHESTER, PA -- October 21, 2003 -- Cephalon, Inc. (Nasdaq: CEPH) announced today that the company has received an approvable letter from the U.S. Food and Drug Administration (FDA) to expand the label for Provigil® (modafinil) [C-IV] beyond treatment for excessive daytime sleepiness associated with narcolepsy. The letter states that Provigil is approvable for improving wakefulness in patients with excessive sleepiness associated with shift work sleep disorder and in patients with obstructive sleep apnea/hypopnea syndrome. Cephalon expects to launch these new indications for Provigil in the first quarter of 2004.
"We look forward to finalizing the process and receiving FDA approval," said Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. "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."
The Peripheral and Central Nervous System Drugs Advisory Committee to the FDA last month recommended that the labeling for Provigil be expanded. That recommendation was based on positive results presented by Cephalon from multiple clinical studies demonstrating the safety and effectiveness of Provigil versus placebo in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.
Provigil is the first in a new class of wake-promoting agents believed to work selectively through the sleep/wake centers to activate the cortex of the brain. Launched in the United States in February 1999, Provigil currently is approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy.
In controlled clinical trials, Provigil has been found to be generally well tolerated with a low incidence of adverse events relative to placebo. The most commonly observed adverse events associated with the use of Provigil in clinical trials include headache, nausea, nervousness, anxiety and insomnia. For full prescribing information about Provigil, please visit http://www.Provigil.com.
SOURCE: Cephalon, Inc.
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