Cephalon Announces Positive Clinical Trial Results for Nuvigil

Cephalon has announced that its Phase III studies of 150- and 250-mg daily doses of Nuvigil 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 (armodafinil) is a single-isomer of the active pharmaceutical ingredient contained in Provigil (modafinil) tablets. The 12-week, double-blind, randomized, placebo-controlled Phase III 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. 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. In these Phase III 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.