Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet La...( ...),Health

Company to Submit a Supplemental New Drug Application to Expand the NUVIGIL(R) Label

FRAZER, Pa., April 6 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced positive results from a phase three clinical trial of NUVIGIL(R) (armodafinil) Tablets [C-IV] as a treatment for excessive sleepiness associated with jet lag disorder. Based on these findings, Cephalon(R) will file a supplemental New Drug Application with the U.S. Food and Drug Administration to expand the indications for NUVIGIL during the third quarter of this year.

The efficacy and safety of NUVIGIL as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years. Participants in the study traveled eastbound from the United States to France where they were then examined at a sleep facility. Clinical efficacy was evaluated using two primary endpoints: an objective assessment -- the Multiple Sleep Latency Test (MSLT), and a subjective assessment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. The results of this study will be submitted for presentation at a future medical meeting.

"After flying the subjects over the Atlantic, we objectively evaluated those receiving placebo versus those receiving NUVIGIL," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. "We discovered that those on placebo were as excessivel
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