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Article: Cephalon Files Application Seeking Additional Indication For PROVIGIL in the United Kingdom; Obstructive Sleep Apnea Clinical Trial Data Submitted for Review to UK Medicines Control Agency (MCA).
- Article from:
- PR Newswire
- Article date:
- March 28, 2002
CopyrightCOPYRIGHT 2002 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WEST CHESTER, Pa. -- Cephalon, Inc. today announced that it has filed a Marketing Authorization Application (MAA) in the United Kingdom to expand the label of PROVIGIL(R) (modafinil) to treat excessive daytime sleepiness in patients with obstructive sleep apnea. PROVIGIL was launched in the U.K. for the treatment of narcolepsy in March 1998.
This application was filed on the basis of positive data generated from two studies of PROVIGIL tablets in more than 480 patients with obstructive sleep apnea. The results of these studies indicate that PROVIGIL may be a useful adjunctive treatment for excessive daytime sleepiness in patients with obstructive sleep apnea ...