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1993.08.02 :  Approval of Felbamate

Contact:  Susan Cruzan (301) 443-3285
August 2, 1993

     The Food and Drug Administration today announced approval of felbamate
to control certain epileptic seizures in adults and a rare form of epilepsy in
children. it is the first now epilepsy drug in more than 10 years.
     About two 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 affects 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.

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HEARING-IMPAIRED.
The new drug was also found safe and affective when added to other
anti-epilepsy drugs in children two 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 &nd 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 affects.
     Clinical development of felbamate began in 1982 as part of the
anticonvulsant 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
Felbatal.
     FDA and NIH are agencies of the U.S. Public Health Service within HHS.