said Monday that its drug Nuvigil alleviated the symptoms of jet lag in a phase III study.
Based on the new data, the company will seek an expanded treatment label with the U.S. Food and Drug Administration in the third quarter.
Cephalon is preparing to launch Nuvigil in the third quarter as a treatment for excessive sleepiness due to a variety of conditions, including sleep apnea and shift work sleep disorder. Nuvigil is a follow-on version of Provigil, Cephalon's top-selling drug with 2008 sales of $988 million. Provigil is scheduled to lose patent protection in 2012.
The jet lag study enrolled 427 adults who were flown eastbound from the U.S. to France and then examined by sleep experts. People treated with Nuvigil were able to sleep better and were less tired than those treated with a placebo over three days, as measured using both objective and subjective tests, Cephalon said. Cephalon recently announced positive results from a phase II study of Nuvigil in patients with bipolar disorder, which could potentially help the drug compete against drugs from
Johnson & Johnson
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