Supplemental NDA submitted for Nuvigil for jet lag disorder

Cephalon announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA requesting approval of Nuvigil (armodafinil tablets) tablets as a treatment for excessive sleepiness associated with jet lag disorder. This sNDA submission is based on a recent Phase 3 study of 427 healthy men and women who all had experienced jet lag symptoms at least once during the previous five years. Clinical efficacy was evaluated using two primary endpoints: an objective assessment — the Multiple Sleep Latency Test (MSLT), and a subjective assessment — the Patient Global Impression of Severity (PGI-S). Patients taking Nuvigil (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05].

Nuvigil is already approved to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD).

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