FDA Fast Tracks Review For Nuvigil as Jet-lag Drug
Reuters reports that Cephalon's drug for excessive sleepiness called Nuvigil has landed a fast track review from the FDA for jet-lag. The FDA is expected to decide by Dec. 29 whether to approve Nuvigil for people suffering from jet-lag.
Specifically, the FDA is reviewing Nuvigil as a treatment for "improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel," Cephalon said.
There are currently no FDA-approved treatments for "jet lag disorder," according to Cephalon.
With priority review status, the FDA will make its decision on whether to approve the drug within six months, rather than the usual 10- to 12-month review period. The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.
Nuvigil launch in June, 2009 for people suffering from an excessive sleep disorder. The website says it it meant for people with obstructive sleep apnea (OSA), shift work disorder (SWD) and narcolepsy. Side effects listed on the website include headache, nausea, dizziness, and trouble sleeping. The drug's website also warns that Nuvigil may "may cause you to have a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening."
Reuters 
