NUVIGIL improves wakefulness in patients with excessive sleepiness associated with shift work disorder

Nov 3 2009

Cephalon, Inc. (Nasdaq: CEPH) today announced that the November issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial demonstrating that NUVIGIL® (armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD). NUVIGIL, the longer-lasting isomer of modafinil, is indicated to improve wakefulness in patients with excessive sleepiness associated with shift work disorder, treated obstructive sleep apnea and narcolepsy. These data were part of the new drug application approved by the FDA in 2007.

This Phase III 12-week, randomized, double-blind, placebo-controlled study evaluated 254 permanent or rotating shift workers with shift work disorder at 42 sleep research centers in the United States and Canada. Study patients received NUVIGIL (150 mg) or a placebo at approximately one hour before each night shift. During weeks four, eight and 12, patients spent a night shift in the sleep laboratory, where investigators assessed patients' physiological propensity to fall sleep during night shift hours and clinicians' impression of disease severity, and patient-reported level of sleepiness.

The study showed that patients wakefulness significantly improved over the course of the trial in patients taking NUVIGIL (by 3.1 minutes) versus those on placebo (by 0.4 minutes) (P<0.001). This primary endpoint was evaluated by the Multiple Sleep Latency Test, which measured patients' time to fall asleep at specific times during the night shift.

"These findings are important, given that approximately 15 percent of U.S. employees work during nighttime hours and many may have symptoms of shift work disorder," said Thomas Roth, PhD, director of the Henry Ford Hospital Sleep Disorders and Research Center in Detroit and an investigator in the study. "The results establish the potential benefits of armodafinil (NUVIGIL) for patients with excessive sleepiness associated with shift work disorder."

Researchers also found that a significantly greater proportion of patients receiving NUVIGIL (79 percent) than placebo (59 percent)>

In this study, NUVIGIL was not found to affect daytime sleep, as measured by polysomnography (an objective measure of sleep), although two percent of patients reported insomnia. The most commonly reported adverse events in patients who received NUVIGIL were headache, nausea, nasopharyngitis (inflammation of the nasal passages and the upper throat) and anxiety.