Biotech Values

[DewDiligence]

FDA Issues CRL for CEPH’s Nuvigil

[Nuvigil consists of the “R” stereoisomer of CEPH’s blockbuster Provigil, which loses US marketing exclusivity in Apr 2012 (as a result of litigation settlements). Nuvigil was approved in 2007 (#msg-20529938) and has indications for excessive sleepiness associated with sleep apnea, narcolepsy, and shift work; however, its commercial uptake has been slow because Nuvigil offers little or no medical benefit relative to Provigil.

The Nuvigil NDA in question is for Jet Lag Disorder (seriously). The FDA is questioning CEPH’s data on the co-primary endpoint called Patient Global Impression of Severity, which is subjective. This would seem to be a case where an SPA would have been helpful.]

http://finance.yahoo.com/news/Cephalon-Receives-Complete-prnews-747667846.html?x=0&.v=1

›Cephalon Receives Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

Monday March 29, 2010, 4:47 pm EDT

FRAZER, Pa., March 29 /PRNewswire-FirstCall/ -- 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 [p=0.044]. The most common adverse events associated with NUVIGIL treatment (five percent or greater) were headache, nausea, insomnia, diarrhea and palpitations. There were no reports of serious rash observed in the trial participants, and no new safety signals were observed in the clinical trial.

"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."‹