Cephalon, Inc. announced that the November 2009 issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial of Nuvigil (armodafinil) Tablets [C-IV] demonstrating it significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD).
Nuvigil, a longer-lasting formulation 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 U.S. Food and Drug Administration (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 (MSLT), 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) (P=0.001) improved, as evaluated by Clinical Global Impressions of Change (CGI-C), which measured overall well-being as related to sleepiness during night shifts including the commute to and from work.
In addition, patients taking Nuvigil showed improvement as measured by the Karolinska Sleepiness Scale (KSS), a patient-related subjective measure of sleepiness.
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.
About Shift Work Disorder
Shift work disorder is an important yet seldom recognized medical condition in which a person’s internal clock, which helps regulate the cycle of sleeping and waking, is out of sync with his or her work schedule.
The disorder is often triggered when people work outside of traditional work hours. Those affected by shift work disorder experience excessive sleepiness or insomnia to an extent that it is difficult for them to function effectively at work.
About Nuvigil
Nuvigil 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.
The Nuvigil label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, which 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 the medication). Nuvigil is not approved for use in pediatric patients for any indication.
Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.
Although Nuvigil has not been shown to produce functional impairment, any drug affecting the central nervous system may alter judgment, thinking or motor skills.
Patients should be cautioned about operating an automobile or other hazardous machinery until reasonably certain that Nuvigil therapy will not adversely affect their ability to engage in such activities.
The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia. Full prescribing information is available at www.nuvigil.com.
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