FDA Approves Cephalon's Sleep-Disorder Drug Nuvigil

Cephalon is celebrating after US regulators at last gave the green light to Nuvigil, its new compound for excessive sleepiness and a longer-acting version of its biggest earner Provigil.

The US Food and Drug Administration has approved the non-amphetamine wake-promoting agent Nuvigil (armodafinil) for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder. The decision comes a year after the FDA delayed approval of Nuvigil over a problem with labelling, which was complicated by the agency's review of another product based on modafinil, Sparlon for attention-deficit hyperactivity disorder.

The latter was rejected on concerns about a child who suffered a serious skin reaction - known as Stevens-Johnson Syndrome - after taking the drug. However, the FDA has now approved final labelling for Nuvigil, which will include a bolded warning about Stevens Johnson Syndrome (SJS) and other skin rashes and hypersensitivity.