FRAZER, Pa., March 31 /PRNewswire-FirstCall/ — Cephalon, Inc. (Nasdaq: CEPH – News) announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration seeking approval to market NUVIGIL(TM) (armodafinil) Tablets [C-IV] to improve wakefulness in patients suffering from excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD) and obstructive sleep apnea/hypopnea syndrome (OSA/HS). NUVIGIL is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGILÂ® (modafinil) Tablets [C-IV].
The NDA is based on positive results of four double-blind, randomized, placebo-controlled studies of NUVIGIL in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSA/HS. The data in this filing show that the primary endpoints of all studies were met and suggest that NUVIGIL is differentiated from PROVIGIL.
“This is the third of five FDA approvals that we will be pursuing over a 15-month time period,” said Dr. Paul Blake, Executive Vice President, Worldwide Clinical Research & Regulatory Affairs at Cephalon. “Cephalon is a pioneer in developing compounds for improving wakefulness, and this on- schedule filing allows us to reinforce our leadership position in the treatment of disorders of sleep and wakefulness,” added Dr. Blake.
About the Clinical Studies
In four, 12-week studies, daily doses of 150 and 250 milligrams of NUVIGIL or placebo were administered to approximately 1,000 patients with excessive sleepiness associated with either narcolepsy, OSA/HS or SWSD. The primary endpoints in all studies were measures of objective sleep latency (Maintenance of Wakefulness Test or Multiple Sleep Latency Test) and the physician rating of Clinical Global Impression-Change. In each study, patients treated with NUVIGIL showed a statistically significant improvement on both primary endpoints compared to placebo (all p values <0.05). Moreover, recordings and patient diaries showed that compared with placebo, NUVIGIL did not disturb patients' normal sleep schedule.
In these Phase 3 studies, NUVIGIL was generally well tolerated, with a safety profile consistent with that observed in studies of PROVIGIL. The most common adverse effects observed included headache, nausea, dizziness, insomnia and anxiety.
About Excessive Sleepiness
Excessive sleepiness is the primary symptom – and often the most debilitating feature – patients experience with OSA/HS, SWSD and narcolepsy. Associated with a reduction of activity in the cerebral cortex of the brain, the defining characteristic of excessive sleepiness is a consistent inability to stay awake and alert enough to safely and successfully accomplish tasks of daily living. While millions of Americans suffer from excessive sleepiness associated with narcolepsy, OSA/HS and SWSD, they are often misdiagnosed and the rate of underdiagnosis has been estimated to be between 50 to 90 percent. Persons experiencing excessive sleepiness who seek medical attention typically complain of fatigue, tiredness, lapses of attention, lack of energy, low motivation, difficulty concentrating, disrupted sleep, snoring or difficulties at work.
Cephalon currently employs approximately 2,300 people in the United States and Europe. U.S. sites include the company's corporate headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European offices are located in Guildford, England, Martinsried, Germany, and Maisons-Alfort, France.
The company currently markets three proprietary products in the United States: PROVIGIL, GABITRILÂ® (tiagabine hydrochloride) Tablets and ACTIQÂ® (oral transmucosal fentanyl citrate) [C-II], and more than 20 products internationally. Further information about Cephalon and 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, particularly with respect to the NUVIGIL Phase 3 trials, prospects for regulatory approval of NUVIGIL, anticipated product launch date and potential benefits of NUVIGIL, 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.