Mayo Clinic Proceedings Publishes Study of NUVIGIL in Patients with Shift Work Disorder
FRAZER, Pa., Nov. 2 /PRNewswire-FirstCall/ -- 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) (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 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.
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 NUVIGIL). 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 for NUVIGIL is available at www.NUVIGIL.com.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing 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 countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.
The company's proprietary products in the United States include: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com/www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
SOURCE: Cephalon, Inc
Posted: November 2009