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Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet Lag Disorder
Date:4/6/2009

y sleepy as narcoleptics and that the treatment effect for those on NUVIGIL was the largest we have seen to date. We are pleased that this positive study will allow us to file our first sNDA for an acute use of NUVIGIL."

NUVIGIL was generally well-tolerated in the study. The adverse events reported in this study of acute use are consistent with chronic use in the current NUVIGIL label. The most common adverse events in the study, observed more frequently with NUVIGIL use, included headache, anxiety, nausea, palpitations and fatigue.

Jet lag disorder is an acute circadian rhythm sleep disorder that results from rapid travel across several time zones. This disorder affects approximately 70 million American travelers annually and gradually resolves once a person adjusts to the new local time.

Circadian rhythm sleep disorders are disruptions in a person's internal body clock, which controls sleep patterns. When the internal body clock is disrupted, certain symptoms may develop affecting a person's ability to sleep, stay awake and function normally. Circadian rhythm sleep disorders can be caused by many factors, including shift work, time zone changes and medications.

Cephalon is preparing to launch NUVIGIL, the longer-lasting isomer of modafinil, in the third quarter of 2009. NUVIGIL is not approved for the treatment of jet lag disorder or its associated symptoms. The U.S. Food and Drug Administration-approved prescribing information for NUVIGIL, including bolded warnings, is available at www.NUVIGIL.com.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of
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SOURCE Cephalon, Inc.
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