FDA to Review Cephalon for Excessive Sleepiness

24 September 2009 (Last Updated September 24th, 2009 18:30)

The US Food and Drug Administration (FDA) has granted a priority review for Cephalon's Nuvigil, a new treatment for excessive sleepiness associated with jet lag. Nuvigil, which would be the first jet lag treatment approved by the FDA, is indicated to improve wakefulness in patients with t

The US Food and Drug Administration (FDA) has granted a priority review for Cephalon's Nuvigil, a new treatment for excessive sleepiness associated with jet lag.

Nuvigil, which would be the first jet lag treatment approved by the FDA, is indicated to improve wakefulness in patients with treated obstructive sleep apnea, shift work sleep disorder and narcolepsy.

The new drug application filed by Cephalon is based on data from a Phase III pivotal study that evaluated the efficacy and safety of Nuvigil (50 or 150mg/day) in 427 healthy adults over three days during travel from the US to Europe.

The most common adverse events in controlled clinical trials were headache, nausea, dizziness and insomnia.