CEPHALON WORKING WITH FDA TO FINALIZE NUVIGIL LABELING

Cephalon has provided an update on the status of its new drug application (NDA) for Nuvigil (armodafinil). The company announced that the FDA said it is continuing to evaluate the single case of serious rash reported in a clinical study of Sparlon (modafinil). The agency has requested additional information to help place this isolated case in the context of the safety profile of modafinil. The FDA has not requested any additional information related to Nuvigil and is working with the company to finalize the product's label.

Nuvigil is a single-isomer formulation of modafinil. The Nuvigil NDA is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness. In these studies, Nuvigil was generally well-tolerated.

In May the company announced that it had received an approvable letter from the FDA for the NDA requesting approval of Nuvigil for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. FDA approval of Nuvigil is contingent upon finalizing the product label.