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Armodafinil Significantly Improves Wakefulness in Phase 3 Studies
The 12-week, double-blind, randomized, placebo-controlled Phase 3 studies of approximately 1,000 patients included one study of excessive sleepiness in narcolepsy, one study in SWSD and two studies in OSA/HS. The primary endpoints in all studies were measures of objective sleep latency (Maintenance of Wakefulness Test or Multiple Sleep Latency Test) and the physician rating of Clinical Global Impression-Change. These primary endpoints are identical to those studied for the currently approved indications for PROVIGIL. In each study, patients treated with NUVIGIL showed a statistically significant improvement on both primary endpoints compared to placebo (all p values In these Phase 3 studies, NUVIGIL was generally well tolerated, with a safety profile consistent with that observed in other studies of PROVIGIL. The most common adverse effects observed included headache, nausea, dizziness, insomnia and anxiety.
The complete data on these four studies are expected to be presented at several major medical meetings in 2005, including the Associated Professional Sleep Societies meeting in June. Cephalon expects to file a New Drug Application for NUVIGIL on schedule with the U.S. Food and Drug Administration (FDA) this quarter.
"We expect to deliver a filing that highlights the safety and efficacy of NUVIGIL for these patient populations and demonstrates clinical improvements in fatigue and cognition, as well as a long duration of action without affecting the patient's normal sleep schedule," said Dr. Paul Blake, Senior Vice President, Clinical Research and Regulatory Affairs, at Cephalon.
Source: Cephalon, Inc.