Cephalon files supplemental new drug application for Nuvigil

Wed. July 01, 2009; Posted: 01:11 PM

Jul 01, 2009 (Datamonitor via COMTEX) -- CEPH | Quote | Chart | News | PowerRating -- Cephalon, a biopharmaceutical company, has submitted a supplemental new drug application to the FDA requesting approval of Nuvigil tablets for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

The Nuvigil supplemental new drug application (sNDA) for the treatment of excessive sleepiness associated with jet lag disorder is based on data from a phase III study. The data from this novel placebo-controlled pivotal study, which involved overseas air travel, included an evaluation of the efficacy and safety of Nuvigil (50 or 150mg/day) in 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 (150mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05], Cephalon said.

Lesley Russell, chief medical officer and executive vice president at Cephalon, said: "This supplemental new drug application for a new use of Nuvigil is another important milestone for Cephalon. We hope that this will be the first of many new indications for Nuvigil over the next five years."

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For full details on Cephalon Inc (CEPH) click here. Cephalon Inc (CEPH) has Short Term PowerRatings of 4. Details on Cephalon Inc (CEPH) Short Term PowerRatings is available at This Link.

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