ANSWERS
06/22/1995

<TITLE>FDA AUTHORIZES TREATMENT IND FOR LOU GEHRIG'S DISEASE</TITLE>
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T95-29                                         Susan M. Cruzan
June 22, l995                                  301-443-3285

      FDA AUTHORIZES TREATMENT IND FOR LOU GEHRIG'S DISEASE
     FDA has authorized treatment IND (investigational new drug)
status for riluzole for patients with amyotrophic lateral sclerosis
(ALS), also known as Lou Gehrig's disease.  Patients with ALS
suffer progressive muscular weakness and paralysis; there is no
cure.  The following can be used to answer questions.
     FDA's treatment IND regulations offer a mechanism that allows
drug developers to provide earlier and wider access to
investigational therapies for patients with immediately life-
threatening or otherwise serious diseases for which there is no
satisfactory alternative drug treatment.  A treatment IND permits
this expanded use while further data are developed during the
clinical investigation of the drug that precedes the submission of
a marketing application.
     Although riluzole is not a cure for ALS, two placebo-
controlled studies showed improvements in survival rates among
patients on the drug.  At one year 74 percent of patients taking
riluzole in one study were alive compared to 58 percent on placebo. 
In another study, at 18 months, 57 percent of patients taking
riluzole were alive compared to 50 percent on placebo.  However,
Riluzole has not been shown to improve symptoms of ALS.
     Riluzole is distributed by Rhone-Poulenc Rorer Inc. of 
Collegeville, Pa., under the trade name Rilutek.

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