The company received a second Complete Response Letter from the FDA for the supplemental new drug application for NUVIGIL Tablets for the treatment of patients with excessive sleepiness associated with jet lag. 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.”