Cephalon’s wakefulness pill Nuvigil (armodafinil) granted priority review in US

Nuvigil (armodafinil) to keep people awake after excessive sleepiness from Cephalon has been granted priority review by US FDA.

Nuvigil (armodafinil) is a longer-lasting isomer of modafinil. The exact mechanism of action is unknown. Armodafinil belongs to a class of drugs known as eugeroics, which are stimulants that provide long-lasting mental arousal.

Nuvigil is specifically indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD).

Nivigil is supplied as a 50 mg, 150 mg or 250 mg tablet designed for oral administration. The recommended initial dose of the drug for the treatment of OSAHS and narcolepsy is 150 mg or 250 mg given as a single dose in the morning. The recommended initial dose of the drug for the treatment of SWSD is 150 mg given daily approximately one hour prior to the start of the work shift.

Nuvigil (armodafinil) 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.

Cephalon has filed a supplemental New Drug Application (sNDA) for Nuvigil (armodafinil) tablets in June of this year.

US FDA granted a priority review for for Nuvigil (armodafinil) as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.

Cephalon expects US FDA decision on approval of Nuvigil for jet lag disorder by December 29.

Currently, there is no FDA-approved treatment for jet lag disorder.

Nuvigil  sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of armodafinil 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.

Nuvigil (armodafinil) is not approved as a treatment for jet lag disorder or its associated symptoms.

Nuvigil (armodafinil) 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.

Cephalon, Inc. is a 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.

Cephalon is 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. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.