Mayo Clinic Proceedings Publishes:
Study of NUVIGIL
in Patients with
Cephalon, Inc. announced that the November issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial demon- strating 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 approxi- mately one hour before each night shift. During weeks four, eight and 12, patients spent a night shift in the sleep laboratory, where investiga- tors 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) ver- sus 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 symp- toms 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 ben- efits 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 wellbeing 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 meas- ured 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, nau- sea, 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 con- dition 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 func- tion effectively at work.
Shift Work Disorder
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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, 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.
Patients should be advised that their level of wake- fulness may not return to normal. Patients should be frequently reassessed for their degree of sleepi- ness and, if appropriate, advised to avoid driving or any other potentially dangerous activity. Although NUVIGIL has not been shown to pro- duce functional impairment, any drug affecting the central nervous system may alter judgment, think- ing 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 for NUVIGIL is available at www.NUVIGIL.com.
ABOUT CEPHALON Founded in 1987, Cephalon, Inc. is an internation- al biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory dis- eases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in
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the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manu- facturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European coun- tries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology. Full prescribing information on its U.S. products is available at www.cephalon.com or by calling 1- 800-896-5855.
[i] US Department of Labor, Bureau of Labor Statistics. Workers on flexible and shift schedules. Bureau of Labor Statistics Web site. http://www.bls.gov/news.release/pdf/flex.pdf. Accessed on October 23, 2009. [ii] Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. Philadelphia: WB Saunders; 2005. [iii] Waage S; Moen BE; Pallesen S; Eriksen HR; Ursin H; Åkerstedt T; BjorvatnB. Shift work disor- der among oil rig workers in the North Sea. SLEEP 2009;32( 4):558-565. [iv] Ohayon MM, Lemoine P, Arnaud-Briant V, Dreyfus M. Prevalence and consequences of sleep disorders in a shift worker population. J Psychosom Res. 2002;53( 1):577-583. [v] Schwartz JRL, Roth T. Shift work sleep disor- der: burden of illness and approaches to manage- ment. Drugs. 2006;66(18):2357-2370.
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