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Cephalon Announces Positive Topline Results From a Phase IV Study of NUVIGIL in Shift Work Disorder
Date:1/25/2011

ents taking NUVIGIL in this study.  The first presentation of these data will occur during the Society of General Internal Medicine's 34th Annual Meeting in May 2011.  Additional results also will be submitted for future publications and presented at medical meetings.  

According to the U.S. Department of Labor, over 15 million Americans work odd hours or non-traditional shifts, and are "at risk" for shift work disorder.  Shift work disorder occurs when the body's internal sleep-wake clock is out of sync with the individual's work schedule -- their body is telling them to go to sleep when their work schedule needs them to stay awake. Because of this disruption of the body's natural rhythm, people with shift work disorder often struggle to stay awake during their waking hours (excessive sleepiness), or have trouble sleeping during their sleeping hours (insomnia).

About NUVIGIL NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.  In patients with OSA, NUVIGIL is used along with other medical treatments for this condition.  The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of 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 .

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SOURCE Cephalon, Inc.
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