U.S.
Modafinil is a drug developed in France by Lafon Pharmaceuticals. It has been used for the treatment of narcolepsy in France for the past 10 years. In the United States, Cephalon, Inc (West Chester, Pa) has conducted double blind clinical trials of the efficacy and safety of Modafinil at approximately 40 sites in the United States. The Center for Narcolepsy Research is one of the clinical trial sites.
About 600 persons with narcolepsy participated
in the trials. Subjects in the double blind phase of the study took a daily
a.m. dose of 200 mg, 400mg or placebo for the 9-week double blind phase.
The preliminary analysis of the data from all the sites indicated that
persons taking modafinil were significantly more alert than those
on placebo, and that the 400mg dose was significantly
more effective than the 200mg dose. The conclusion was that modafinil is
an effective and safe drug for treating the sleepiness associated with
narcolepsy. Generally, subjects in the study reported that modafinil was
alerting but they did not feel "edgy" or jittery while
taking it. Many of these people took modafinil
in the dose they felt was best for them for the extended open label phase
of the study.
The Food and Drug Administration (FDA) has approved
modafinil pending review by the Drug Enforcement Administration of the
labeling that will accompany the compound. Availability anticipated in
late fall, 1998. Cephalon plans to market modafinil under the name "Provigil".
Cephalon has a web site dealing with excessive daytime sleepiness that
you can reach by clicking here:
http://www.daytimesleep.org
For more information about Modafinil, contact Cephalon at 145 Brandywine Parkway, Westchester, PA, 19380-4245, (800)41-AWAKE.
Canada
Modafinil is already available for use in Canada. The license agreement restricts Draxis, the company with licensing rights, to distribution in Canada. A health care provider can obtain information about prescribing the drug by contacting Jeremy Hill, Manager, New Drug Development at:
(905)677-5500
FAX: (905)677-9263
Email: jhill@draxis.com