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| |  Provigil Now Available In The U.S. For Narcolepsy WEST CHESTER, PA -- Feb. 16, 1999 -- Cephalon, Inc.’s Provigil(R) (modafinil) Tablets [C-IV], a novel, wakefulness-promoting agent for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy, is now available in the United States. Provigil was approved by the U.S. Food and Drug Administration on Dec. 24, 1998. "Narcolepsy is an extremely serious medical condition that can significantly impair a person's ability to perform everyday functions,” said Dr. Wolfgang Schmidt-Nowara, M.D., a Provigil clinical investigator, immediate past president of the American Sleep Disorders Association (ASDA), and a physician with the Sleep Medicine Institute of Presbyterian Hospital in Dallas, TX. “The availability of Provigil to treat the most prevalent and debilitating symptom of narcolepsy -- excessive daytime sleepiness -- is a much anticipated and greatly welcomed advance in the treatment of this condition." Narcolepsy is a chronic, lifelong neurological sleep disorder of unknown origin afflicting an estimated 125,000 people in the U.S. Narcolepsy can strike people of both sexes and all races, with symptoms generally first appearing in a person's teens and early 20s. The symptoms of narcolepsy include excessive daytime sleepiness, sudden loss of muscle control known as cataplexy, sleep paralysis and vivid hallucinations at the onset of sleep known as hypnagogic hallucinations. Provigil is a unique, wakefulness-promoting agent. In landmark clinical trials involving more than 550 patients with narcolepsy, Provigil was found to be efficacious in improving daytime wakefulness. Patients also demonstrated overall clinical improvement in the severity of their disease symptoms. Provigil has been found to be generally well-tolerated, with a low incidence of adverse events relative to placebo. In controlled clinical trials, most adverse events were mild to moderate. The most commonly observed were headache, infection, nausea, nervousness, anxiety and insomnia. No specific symptoms of withdrawal were observed after discontinuation of Provigil therapy. The dose of Provigil is 200 mg/day, given as a single dose in the morning.
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