Cephalon, Inc. has filed a New Drug Application (NDA) with the US FDA seeking approval to market Nuvigil (armodafinil) Tablets [C-IV] to improve wakefulness in patients suffering from excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD) and obstructive sleep apnea/hypopnea syndrome (OSA/HS). Nuvigil is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil (modafinil) Tablets [C-IV].

The NDA is based on positive results of four double-blind, randomized, placebo-controlled studies of Nuvigil in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSA/HS. The data in this filing show that the primary endpoints of all studies were met and suggest that Nuvigil is differentiated from Provigil, the company release said.

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. In each study, patients treated with Nuvigil showed a statistically significant improvement on both primary endpoints compared to placebo. Moreover, recordings and patient diaries showed that compared with placebo, Nuvigil did not disturb patients' normal sleep schedule.

In these Phase 3 studies, Nuvigil was 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.

Excessive sleepiness is the primary symptom - and often the most debilitating feature - patients experience with OSA/HS, SWSD and narcolepsy. Associated with a reduction of activity in the cerebral cortex of the brain, the defining characteristic of excessive sleepiness is a consistent inability to stay awake and alert enough to safely and successfully accomplish tasks of daily living.