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Cephalon Says Nuvigil Drug Improved Wakefulness in Late-Stage Trial
Posted on 2005-02-10 06:03:00
Cephalon Inc. said Thursday that a late-stage study found its most recent drug for excessive sleepiness, Nuvigil, significantly improved wakefulness and the overall clinical condition of patients. Nuvigil works similarly to Cephalon's Provigil tablets, already on the market as a treatment for excessive sleepiness associated with narcolepsy, shift work sleep disorder or obstructive sleep apnea/hypopnea syndrome.
The company said the 12-week study involved about 1,000 patients with one of those three disorders. In each group, Nuvigil significantly improved a key measure called "sleep latency." The drug also promoted wakefulness later in the day without impairing sleep, indicating that it continues to work over a long period, the company said.
Cephalon said the most common side effects included headache, nausea, dizziness, insomnia and anxiety. The company plans to file an application for Nuvigil with the Food and Drug Administration this quarter.
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