Cephalon, Inc. has announced that its Phase 3 studies of 150- and 250-milligram daily doses of Nuvigil (armodafinil) in patients suffering from either excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD) or obstructive sleep apnea/hypopnea syndrome (OSA/HS) show that the medication significantly improves wakefulness and the overall clinical condition of patients as compared to placebo. Nuvigil is a single- isomer of the active pharmaceutical ingredient contained in Provigil (modafinil) Tablets.

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. The studies also demonstrated that Nuvigil promotes wakefulness later in the day without impairing sleep, thereby establishing that it has a long duration of action, a company release said.

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.

Cephalon expects to file a New Drug Application for Nuvigil on schedule with the US 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 VP, Clinical Research and Regulatory Affairs, at Cephalon.