NEWS
08/02/1993

<TITLE>FDA Approves FELBAMATE</TITLE>
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P93-33                               Food and Drug Administration
FOR IMMEDIATE RELEASE                Susan Cruzan - (301)443-3285

    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 new 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
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. 
                             -MORE-


                                          Page 2, P93-33, Felbamate
    The new drug was also found safe and effective 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
antiepilepsy 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 antiepilepsy drugs, doctors should
adjust doses of the other drugs in order to decrease the likelihood
of side effects.                  
    Clinical development of felbamate began in l982 as part of the
anticonvulsant program of the National Institutes of Neurological
Disorders and Stroke of the National Institutes of Health.  On Dec.
14, l992, 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.
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