Rilutek (riluzole)
Company: Rhone Poulenc Rorer
Approval Status: Approved December 1995
Treatment for: amyotrophic lateral sclerosis
Areas: Neurology
| General Information | Clinical Results | Side Effects | Literature References | Additional Information |
General Information
Rilutek is the first drug shown to provide some benefit to people with amyotrophic lateral sclerosis. No treatment has previously been available for this fatal, neurodegenerative disease since it was first described 126 years ago.
Clinical Results
In the largest ALS clinical trial ever, Rilutek was shown to extend the survival of ALS patients by three months. A total of 959 patients participated in a multicenter, double-blind, placebo-controlled phase III trial, in which survival served as the primary endpoint.
Side Effects
In addition to demonstrating a survival benefit, Rilutek was generally well tolerated. Side effects reported in the trial included nausea, fatigue, and elevated liver enzymes.
Literature References
Advances in Neurology, Vol. 68, Lippincott-Raven Publishers, 1995
Additional Information
The outward signs of ALS are progressive weakness and deterioration of the muscles (amyotrophic), beginning in the limbs, usually on one side of the body (lateral). Inside the body, the nerves controlling motor function die off after their cell bodies become hardened and shriveled (sclerosis), leaving the patient increasingly helpless.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
