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FDA ADVISORY COMMITTEE REACHES UNANIMOUS APPROVAL RECOMMENDATION OF NEURONTIN FOR EPILEPSY

 MORRIS PLAINS, Dec. 15 /PRNewswire/ -- The Parke-Davis division of Warner-Lambert Company (NYSE: WLA) announced today that an advisory committee to the Food and Drug Administration recommended Neurontin (gabapentin) for approval as a new add-on epilepsy therapy.
 The Peripheral and Central Nervous System Drugs Advisory Committee concluded a review of clinical information related to the efficacy and safety of Neurontin. Data presented from controlled clinical trials demonstrated improved levels of control of refractory partial seizures with or without secondary generalized seizures. In addition, the committee reviewed findings that point to gabapentin's favorable drug- drug interactions profile and unique mechanism of action.
 "We believe that the committee's recommendation is based on sound clinical evidence if approved for marketing by the FDA, gabapentin will be a valuable addition to the therapeutic armamentarium for refractory patients," said Mark Pierce, M.D., Ph.D., vice president, CNS, at Parke-Davis Pharmaceutical Research.
 "Since we have not seen any drug-drug interactions with gabapentin, physicians may be more inclined to add it to existing therapy than take the risk of entirely changing patients' medication," added Pierce.
 Gabapentin is a novel anticonvulsant that does not bind significantly to plasma proteins, which reduces the potential for drug- drug interactions with other anticonvulsants. Data presented by Parke- Davis indicates favorable results when used as add-on therapy to other existing anticonvulsant therapies.
 Parke-Davis has conducted gabapentin clinical trials since 1986 in the United States and Europe in 792 patients which have shown favorable results when used as add-on therapy to other currently prescribed anticonvulsant medications.
 Epilepsy is a serious central nervous system disorder affecting 2.5 million people a year in the United States and for which there in no cure. Approximately 25-30 percent of all epilepsy patients are refractory to currently marketed anticonvulsants. These refractory patients generally require highly individualized treatment to determine adequate doses of one or several therapies.
 Parke-Davis, a division of Warner-Lambert Company, has a long heritage in epilepsy research and treatment. It's drug Dilantin, is one of the most prescribed anticonvulsant with 51 percent of the market.
 Warner-Lambert is a worldwide company devoted to the discovery, development, manufacturing and marketing of quality healthcare products. It employs approximately 34,000 people.
 -0- 12/15/92
 /CONTACT: Peter Wolf, 201-540-6696, or Nancy Fitzsimmons, 201-540-2145, for Warner-Lambert, or Karen Arena of Burson-Marsteller, 212-614-4224, for Warner-Lambert/
 (WLA)


CO: Parke-Davis; Warner-Lambert Company ST: New Jersey IN: MTC SU:

SH-SM -- NY055 -- 7313 12/15/92 15:01 EST
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Publication:PR Newswire
Date:Dec 15, 1992
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