Cephalon Reports New Research Results for Provigil®

Chicago, IL - June 7, 2001

Data from two new studies demonstrate that patients receiving Provigil® (modafinil) Tablets, for treatment of the excessive daytime sleepiness associated with narcolepsy, experience a sustained treatment response and that the response may be related to drug dosage. These data, along with other studies of Provigil in sleep-related disorders, were presented at the 15th Annual Meeting of the Associated Professional Sleep Societies in Chicago.

Long Term Safety

In one study patients with narcolepsy, who participated in the open label portion of the pivotal clinical trials, were followed for 136 weeks, to assess the long-term safety and efficacy of Provigil. Data on the patients completing the 136 weeks of the open-label study show that Provigil provided a sustained treatment response in patients for more than 2.5 years. During that time period, more than 70 percent of patients received 400-mg maintenance doses of Provigil. The adverse events in this study were similar to those reported in the pivotal double-blind clinical trials.

"We are pleased that with more than 2 years of open label study, Provigil has shown a well-tolerated and predictable safety profile and a continuous treatment response without evidence of tolerance for narcolepsy patients," said Jonathan Schwartz, M.D. of Integris Sleep Disorders Center of Oklahoma in Oklahoma City, OK.

Dosing Study

Additionally, in a 13 week double-blind randomized study of 32 patients with narcolepsy, sleepiness was assessed using the extended Maintenance of Wakefulness Test (MWT) and the overall clinical effect was assessed using the Clinical Global Impression of Change (CGI-C) scale. Patients received either a 200-mg or 400-mg dose once a day or a divided 400-mg dose.

Approximately 80 percent of patients receiving the 400-mg doses were rated much or very much improved on the CGI-C scale versus 27 percent of patients receiving the once daily 200-mg dose. While all of the doses in the study significantly improved wakefulness, patients receiving 400 mg of Provigil, were significantly more awake than patients receiving 200 mg on both the MWT and the GCI-C. Although these data are promising, additional clinical research is necessary before changes to Provigil labeling could be pursued. There was a low incidence of mild to moderate adverse events observed in the study; the most common were headache, nausea, pain and vomiting.

"This pilot study is the first to objectively show what I have observed in my clinical practice -- excessively sleepy patients with narcolepsy may respond better to the 400 mg dose of Provigil," commented Dr. Schwartz.

Narcolepsy and Provigil

Narcolepsy is a chronic, lifelong neurological sleep disorder of unknown origin afflicting an estimated 200,000 people in the United States. Narcolepsy can strike people of both sexes and all races, with symptoms generally first appearing in the teen years and during early adulthood. 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, wake-promoting agent, which has captured approximately 60 percent of the narcolepsy market since its U.S. launch two years ago. In the largest narcolepsy clinical trials to date, involving more than 550 patients with narcolepsy, Provigil was found to be effective in improving daytime wakefulness. 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.

Cephalon, Inc. markets Provigil in the United States, the United Kingdom, Ireland, and Italy and promotes the product in Austria and Switzerland under the brand name Modasomil®. In addition, Cephalon holds exclusive marketing and distribution rights to Provigil in Japan, South Korea, Taiwan and Latin America.