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FDA APPROVES NEW EPILEPSY DRUG

 WASHINGTON, Aug. 2 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced approval of felbamate to control certain epileptic seizures in adults and a rare form of epilepsy in children. It is the first new epilepsy drug in more than 10 years.
 About 2 million people in the United States are affected by epilepsy, a disorder characterized by seizures. Seizures occur when nerves in the brain fire spontaneously, causing symptoms ranging from shaking of a single arm or leg to loss of consciousness and generalized spasms. In many cases, seizures cannot be adequately controlled with currently available medications.
 "Felbamate provides a new weapon against the debilitating effects of epilepsy," said FDA Commissioner David A. Kessler, M.D. "For those struggling to live with uncontrolled epilepsy, it offers the prospect of a more normal life."
 In clinical trials of several hundred adults, felbamate has been proven effective in reducing seizure frequency with minimal side effects. Felbamate decreases the frequency of partial seizures that start in a localized part of the brain, including those that progress to generalized, so-called grand-mal seizures. In adults, felbamate has been shown to be effective when given alone or in combination with other anti-epilepsy drugs.
 The new drug was also found safe and effective when added to other anti-epilepsy drugs in children 2 years and older with Lennox-Gastaut syndrome. The disorder, which affects about 50,000 children in the United States, is characterized by multiple types of seizures, mental retardation and resistance to standard anti-epilepsy drugs.
 The most common side effects of felbamate include gastrointestinal and nervous system complaints, such as dizziness and vomiting and abdominal pain. The labeling recommends that when it is used with other anti-epilepsy drugs, doctors should adjust doses of the other drugs in order to decrease the likelihood of side effects.
 Clinical development of felbamate began in 1982 as part of the anti- convulsant program of the National Institutes of Neurological Disorders and Stroke of the National Institutes of Health. On Dec. 14, 1992, felbamate was unanimously recommended for approval by FDA's Peripheral and Central Nervous System Drugs Advisory Committee. The new drug, manufactured by Wallace Laboratories of Cranbury, N.J., will be marketed under the trade name Felbatol.
 FDA and NIH are agencies of the U.S. Public Health Service within HHS.
 -0- 8/2/93
 /NOTE TO EDITORS: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the U.S. Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081, /


CO: U.S. Food and Drug Administration; Wallace Laboratories ST: District of Columbia, New Jersey IN: HEA MTC SU:

KD-MH -- DC015 -- 8371 08/02/93 12:30 EDT
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Publication:PR Newswire
Date:Aug 2, 1993
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