I didn’t know the sNDA had an SPA. CEPH’s PR (#msg-48395239) says the FDA is questioning the “robustness” of the PGI-S data, and I interpreted this to mean that the FDA is questioning the validity of using an entirely subjective metric as a co-primary endpoint. However, unless the SPA was invalidated by some kind of protocol violation or the company has been lying to investors (unlikely, IMO, for a company of CEPH’s stature), having an SPA ought to preclude the FDA’s questioning the trial design. This suggests that the FDA’s concern is some kind of procedural issue with respect to collection of the PGI-S data.
CEPH Drops Nuvigil Jet-Lag Application After Second CRL
[Nuvigil, a single-isomer formulation of CEPH’s Provigil, has been a commercial dog. This is not surprising because it Nuvigil confers little or no medical benefit relative to Provigil and is merely a “lifecycle management” gimmick.]
›Cephalon Receives Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated With Jet Lag Disorder
Monday December 27, 2010, 8:30 am
FRAZER, Pa., Dec. 27, 2010 /PRNewswire/ -- Cephalon, Inc. (Nasdaq:CEPH) today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.
"Cephalon believes we met the agreed upon safety and efficacy endpoints in the NUVIGIL sNDA clinical study conducted under a Special Protocol Assessment. However, following several conversations with the agency, and given this second complete response letter, the company believes that further communications with the FDA will not result in an approval of this application," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "As a result, the company is no longer pursuing this indication."
About NUVIGIL
NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. In patients with OSA, NUVIGIL is used along with airway treatments for this condition. The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.‹
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