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news.Shares in Pennsylvania-headquartered Cephalon Inc have risen over 3% after the company posted positive results from phase III studies of its sleep disorders medication, Nuvigil.
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The results show that Nuvigil (armodafinil), a single-isomer of the active pharmaceutical ingredient contained in Cephalon’s Provigil (modafinil), significantly improves wakefulness and the overall clinical condition of patients as compared to placebo.
The phase III studies included one study of excessive sleepiness in narcolepsy, one study in shift work sleep disorder (SWSD) and two studies in obstructive sleep apnea/hypopnea syndrome (OSA/HS).
In each study, patients treated with Nuvigil showed a statistically significant improvement on all 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.
Nuvigil was also generally well tolerated, with a safety profile consistent with that observed in 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, and Cephalon expects to file a new drug application (NDA) for Nuvigil on schedule with the FDA this quarter.