Cephalon, Inc. announced that the company received a second complete response letter from the US Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Nuvigil (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."
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 paediatric patients for any indication.
The most common adverse events in controlled clinical trials (five percent or greater) in labelled indications were headache, nausea, dizziness, and insomnia.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. The company sells numerous branded and generic products around the world.