Data Show That NUVIGIL Improves Excessive Sleepiness Associated with Jet Lag Disorder
FRAZER, Pa., June 10 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) presented results from a pivotal trial that showed NUVIGIL(R) (armodafinil) Tablets [C-IV] significantly improved wakefulness in people with excessive sleepiness associated with jet lag disorder. These phase three data were presented today at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies meeting in Seattle, Washington. NUVIGIL is currently indicated to improve wakefulness throughout the day for the millions of patients who struggle with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder and narcolepsy.
"We know that jet lag disorder affects approximately two-thirds of international travelers and that eastbound flight across multiple time zones can be particularly troublesome. We are excited to present our data at a major scientific meeting about the use of NUVIGIL in acute excessive sleepiness associated with jet lag disorder," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. "Based on the findings of this study, Cephalon will submit a supplemental New Drug Application to the U.S. Food and Drug Administration during the third quarter of this year."
This novel phase three, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy men and women aged 18 to 65 over the course of three days. Study participants all had experienced jet lag symptoms at least once during the previous five years. Participants in the study traveled eastbound from the United States to France, where they were then evaluated at a sleep facility. Clinical efficacy in the study was demonstrated using two measures: an objective assessment (Multiple Sleep Latency Test, MSLT), and a subjective assessment (Patient Global Impression of Severity, PGI-S).
The data showed NUVIGIL significantly improved wakefulness in the participants, as assessed by the MSLT averaged across days one and two. Participants taking NUVIGIL 150mg/day had an average time to fall asleep of 11.7 minutes, compared to 4.8 minutes for subjects taking placebo and 7.7 minutes for subjects taking NUVIGIL 50mg/day (p<0.0001 for both doses compared with placebo). An average time to fall asleep of less than 5 minutes on the MSLT is considered pathological sleepiness and an average time to fall asleep of greater than 10 minutes is considered within the normal range.
Researchers also found that NUVIGIL 150mg/day significantly improved patient-reported clinical condition, as assessed by the mean PGI-S [rating 1=normal to 7=extremely ill], averaged across days one and two, compared with placebo (1.6 armodafinil 150mg/day versus 1.9 placebo; p=0.04). NUVIGIL was generally well-tolerated in the study. The adverse events reported in this study are consistent with the current NUVIGIL label. The most common adverse events observed more frequently with NUVIGIL use compared to placebo (greater than or equal to five percent), included headache, nausea, diarrhea and palpitations.
"Following travel across multiple time zones, many travelers can schedule their meetings or activities to take place after their bodies have adjusted to the local time zone. Others may not have these options and must conduct their daily activities while functionally impaired and excessively sleepy due to the time zone change," said Dr. Richard Bogan, Primary Investigator for the study, Chief Medical Officer of Sleep Med Inc., and Clinical Associate Professor of Medicine,
Jet lag disorder is an acute circadian rhythm sleep disorder that results from rapid travel across several time zones. This disorder affects approximately 70 million American travelers annually and gradually resolves once a person adjusts to the new local time.
Circadian rhythm sleep disorders are disruptions in a person's internal body clock, which controls sleep patterns. When the internal body clock is disrupted, certain symptoms may develop affecting a person's ability to sleep, stay awake and function normally. Circadian rhythm sleep disorders can be caused by many factors, including shift work, time zone changes and medical conditions.
NUVIGIL, the longer-lasting formulation of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD) and narcolepsy. NUVIGIL is not currently indicated for the treatment of jet lag disorder or its associated symptoms. 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.
The most common adverse events in controlled clinical trials (greater than 5 percent) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com.
About Cephalon, Inc.
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 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.
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|SOURCE Cephalon, Inc.|
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