Cephalon Receives Approvable Letter for Nuvigil

Cephalon announced it has received an approvable letter, together with draft labeling, from the FDA for its new drug application (NDA) for Nuvigil for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder.

The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking Nuvigil (armodafinil) and Cephalon's already-approved sleep disorder drug, Provigil (modafinil). The agency also has indicated it will request similar language in the label for Provigil. The proposed labeling is subject to final approval by the FDA.

"We have worked diligently with the FDA over the past six months on this issue, and they have now informed us that their review is complete," Executive Vice President Lesley Russell said. "We are very pleased that the proposed warning language appropriately describes the product's safety profile."

Among other things, the agency has requested that the company provide a standard safety update from clinical trials conducted since June 2006 and samples of promotional materials to be used for the product. The company's response will be submitted within 30 days, and the agency is expected to complete its review within 60 days thereafter. The agency has not requested any additional studies of Nuvigil.

The company originally submitted its NDA for Nuvigil in March 2005 and received an initial approvable letter in April 2006. Cephalon plans to conduct clinical trials evaluating Nuvigil for treating bipolar depression, cognition associated with schizophrenia and excessive sleepiness and fatigue associated with Parkinson's disease and cancer.