Cephalon Submits Supplemental New Drug Application For Nuvigil

Cephalon has submitted a supplemental New Drug Application (sNDA) to FDA for Nuvigil (armodafinil) tablets. It is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder, resulting from eastbound travel.

The data from the placebo-controlled pivotal study, which involved overseas air travel, included an evaluation of the efficacy and safety of Nuvigil (50 or 150 mg/day) in 427 healthy men and women.

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 and the PGI-S, said the company.

Lesley Russell, Executive Vice President and CMO 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.