Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Cephalon, Inc. (Nasdaq: CEPH) today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

As the first company to study a treatment option to improve wakefulness associated with jet lag disorder, Cephalon worked closely with the FDA to design a special protocol assessment (SPA) that would evaluate the experience of a typical eastbound airline traveler.  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>

"Although we reached statistical significance on both primary endpoints, the Complete Response letter raised questions regarding the robustness of the PGI-S data," said Dr. Lesley Russell, Cephalon's Chief Medical Officer.  "We have already reviewed this issue with the FDA and will be scheduling a meeting with the Agency in the near future to discuss it further."