Cephalon Announces Positive Topline Results From a Phase IV Study of NUVIGIL in Shift Work Disorder
Study Focuses on Efficacy of NUVIGIL Late in Shifts, Including Commute Home
FRAZER, Pa., Jan. 25, 2011 /PRNewswire/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced positive results from a phase IV clinical trial of NUVIGIL® (armodafinil) Tablets [C-IV] in patients experiencing excessive sleepiness associated with shift work disorder, specifically during the end of their night shifts (i.e., 4:00 a.m. to 8:00 a.m.), including the commute home. The study data showed statistically significant difference in improvement in overall clinical condition related to late-shift sleepiness in patients receiving NUVIGIL compared to the placebo group. This is the largest trial ever conducted in this patient population, with more than 380 patients randomized to treatment with NUVIGIL or placebo.
The primary outcome measure of this six-week, multicenter, double-blind study of NUVIGIL (150 mg) was the Clinical Global Impression of Change (CGI-C) scale. The CGI-C in this study asked that the clinician rate the patient's improvement in overall clinical condition as it related to sleepiness with shift work disorder late in the shift. Using this rating, the percentage of patients taking NUVIGIL who experienced improvement from baseline was 77 percent versus 57 percent for placebo (p<0.0001). The key secondary outcome was measured using the Global Assessment of Functioning (GAF), a well-recognized assessment of patient functioning found in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Patients receiving NUVIGIL showed a 9.5 point improvement over baseline in the GAF versus a 5.2 point improvement in the placebo group (p< 0.0001).
The most frequently reported adverse events in this study are consistent with those described in the NUVIGIL prescribing information, and include headache, nausea, and insomnia. There were no serious adverse events observed in patients taking NUVIGIL in this study. The first presentation of these data will occur during the Society of General Internal Medicine's 34th Annual Meeting in May 2011. Additional results also will be submitted for future publications and presented at medical meetings.
According to the U.S. Department of Labor, over 15 million Americans work odd hours or non-traditional shifts, and are "at risk" for shift work disorder. Shift work disorder occurs when the body's internal sleep-wake clock is out of sync with the individual's work schedule -- their body is telling them to go to sleep when their work schedule needs them to stay awake. Because of this disruption of the body's natural rhythm, people with shift work disorder often struggle to stay awake during their waking hours (excessive sleepiness), or have trouble sleeping during their sleeping hours (insomnia).
NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. In patients with OSA, NUVIGIL is used along with other medical treatments for this condition. The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of 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.
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, Inc.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at www.cephalon.com.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide the Cephalon 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; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; 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 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.
Candace Steele Flippin
SOURCE Cephalon, Inc.
Posted: January 2011