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Biotech / Medical : CEPH - CEPHALON

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To: Icebrg who wrote (43)	7/11/2003 3:34:49 AM
From: Icebrg	Read Replies (1) of 109

Cephalon Provigil For Improving Wakefulness In Sleep Disorder Patients To Be Discussed By Cmte. Cephalon’s Provigil sNDA for improving wakefulness in patients with excessive sleepiness associated with disorders of sleep and wakefulness will be discussed by FDA’s Peripheral & Central Nervous System Drugs Advisory Committee on Sept. 25. The sNDA filed in December 2002 is based on data from six double-blind, placebo-controlled clinical studies evaluating Provigil (modafenil) versus placebo in more than 1,500 patients. One 12-week randomized double-blind placebo-controlled trial looked at Provigil 200 mg or placebo in 209 patients with a diagnosis of shift work sleep disorder. Provigil patients had significantly improved wakefulness compared to placebo patients, as measured by the Multiple Sleep Latency Test (MSLT) (p<0.01). Provigil patients also showed significant improvement in their clinical condition as measured by the Clinical Global Impression of Change (CGI-C) when compared to patients treated with placebo (p<0.0001). Provigil was approved for excessive daytime sleepiness associated with narcolepsy in December 1998. fdaadvisorycommittee.com

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