Cephalon Presents Positive Results with NUVIGIL in Largest Shift Work Disorder Trial Ever Conducted

FRAZER, Pa., May 6, 2011 /PRNewswire/ -- At the Society of General Internal Medicine's 34th Annual Meeting in Phoenix, Ariz. today, Cephalon, Inc. (Nasdaq: CEPH) presented positive results from a phase IV trial of nearly 400 people with excessive sleepiness associated with shift work disorder.  In the trial, NUVIGIL® (armodafinil) Tablets [C-IV] improved shift-workers' overall clinical condition late in their shifts (i.e., 4:00 a.m. to 8:00 a.m.), including the commute home, compared to placebo. The key secondary endpoint of the study was to assess global function, as measured by the Global Assessment of Functioning (GAF), and patients taking NUVIGIL experienced a greater improvement in GAF score compared to those patients taking placebo. Shift work disorder occurs when the body's internal sleep-wake clock is out of sync with the individual's work schedule – their bodies tell them to go to sleep when their work schedule needs them to stay awake. The primary symptoms of shift work disorder are excessive sleepiness and insomnia.

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This six-week, double-blind, placebo-controlled study of 383 patients with excessive sleepiness associated with shift work disorder was conducted at 45 sites across the United States.  Participants in the study spanned a wide range of occupations associated with shifts or non-traditional work hours, including transportation and material moving, healthcare support, protective services, management roles and office and administrative support.  For the primary endpoint, physicians used the Clinical Global Impression of Change (CGI-C) scale to evaluate the change from baseline (beginning of the study) in overall clinical condition late in the shift – from 4:00 a.m. to 8:00 a.m.  The observation period also included the participant's commute home from work.  Using the CGI-C rating, at the final visit, 77 percent of patients taking the recommended NUVIGIL dose of 150 mg (n=177) improved, compared to 57 percent of patients taking placebo (n=182) – a significantly greater improvement (p

1 Year Cephalon Chart

1 Month Cephalon Chart