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Cephalon – Jet Lag Approval on Fast Track with FDA

Written by: SFD News on September 24th, 2009

Cephalon - Jet Lag Approval on Fast Track with FDA | read this item

Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder

Cephalon today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by December 29, 2009. There currently is no FDA-approved treatment for jet lag disorder.

The NUVIGIL sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy adults over three days during travel from the United States to Europe. These data were presented earlier this year at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies.

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.

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.