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Armodafinil Granted Priority Review as a Treatment Associated with Jet Lag
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.
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.