Sep. 24, 2009 (PR Newswire) --
FRAZER, Pa., Sept. 24 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) 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.
About NUVIGIL
NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.
The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris.
