FDA Grants Priority Review For Cephalon’s NUVIGIL

Cephalon has announced that the FDA has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL (armodafinil) tablets [C-IV], which was filed in June of this year.

The company said that 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.

The NUVIGIL sNDA 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.

NUVIGIL, the longer-lasting isomer of modafinil, was launched in the US in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, (shift work disorder), and narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms.

Cephalon is an international biopharmaceutical company dedicated to the discovery, development and commercialisation of a broad range of products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology.