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NUVIGIL Jet Lag Disorder Data Presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies
Date:6/10/2009

Data Show That NUVIGIL Improves Excessive Sleepiness Associated with Jet Lag Disorder

FRAZER, Pa., June 10 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) presented results from a pivotal trial that showed NUVIGIL(R) (armodafinil) Tablets [C-IV] significantly improved wakefulness in people with excessive sleepiness associated with jet lag disorder. These phase three data were presented today at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies meeting in Seattle, Washington. NUVIGIL is currently indicated to improve wakefulness throughout the day for the millions of patients who struggle with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder and narcolepsy.

"We know that jet lag disorder affects approximately two-thirds of international travelers and that eastbound flight across multiple time zones can be particularly troublesome. We are excited to present our data at a major scientific meeting about the use of NUVIGIL in acute excessive sleepiness associated with jet lag disorder," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. "Based on the findings of this study, Cephalon will submit a supplemental New Drug Application to the U.S. Food and Drug Administration during the third quarter of this year."

This novel phase three, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy men and women aged 18 to 65 over the course of three days. Study participants all had experienced jet lag symptoms at least once during the previous five years. Participants in the study traveled eastbound from the United States to France, where they were then evaluated at a sleep facility. Clinical efficacy in the study was demonstrated u
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