If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Provigil Launched In U.K. For Narcolepsy WEST CHESTER, PA -- March 4, 1998 -- Cephalon, Inc.’s Provigil(R) (modafinil) tablets are now available in the United Kingdom for the treatment of narcolepsy. Narcolepsy is a chronic, neurological, lifelong sleep disorder that generally begins in young adulthood. The most common symptom is excessive daytime sleepiness, which is characterised by uncontrollable sleep attacks. These attacks hamper a person's ability to perform basic daily activities. As a result, narcolepsy significantly impacts a person's quality of life. The most commonly observed adverse experiences associated with the use of the non-amphetamine Provigil, which occurred more frequently than placebo, were headache, nausea and diarrhea. Cephalon estimates that "several thousand" people in Britain suffer from narcolepsy. In the medical literature, calculations of the prevalence of narcolepsy in the general population range from .02% to .06%. The Food and Drug Administration (FDA), which is considering the drug for approval in the United States, granted Provigil orphan drug status in 1993. A 75-patient study by Broughton et al. published in the August 1997 issue of the journal Neurology found no significant differences between the 200 and 400 mg doses of Provigil in increasing mean sleep latency or decreasing the likelihood of falling asleep. The drug increased the mean sleep latency on the Maintenance of Wakefulness Test by 40 percent over placebo for the 200 mg dose and 54 percent for the 400 mg dose, with no statistically significant difference shown between the doses. The Broughton trial showed a dose-response relationship for nausea and anxiety among treated patients, with the 400 mg dose causing more nausea and more nervousness than either of the
|
