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WELLCOME'S LAMICTAL RECOMMENDED AS ADD-ON THERAPY FOR EPILEPSY PATIENTS BY FDA ADVISORY COMMITTEE

 RESEARCH TRIANGLE PARK, N.C., March 20 /PRNewswire/ -- The U.S. Food and Drug Administration's Peripheral and Central Nervous System Advisory Committee has recommended that Lamictal(R) brand lamotrigine be approved as add-on therapy for adult epilepsy patients who experience partial seizures despite current drug therapy.
 The committee, comprised of expert consultants to the FDA, made its unanimous recommendation after reviewing and evaluating the available data on the drug's use in epilepsy patients with poorly controlled seizures.
 The committee's recommendations, while not binding, will be considered by the FDA in its review of the new drug application (NDA) for Lamictal submitted by Burroughs Wellcome Co., a research-based pharamceutical company headquartered in Research Triangle Park, N.C.
 Studies to determine the clinical efficacy and safety of Lamictal were conducted in patients with partial seizures who required more than one anticonvulsant to control their seizures. Approximately 4,700 patients in the United States and throughout the rest of the world have received Lamictal in clinical programs. Two double-blind, placebo- controlled studies conducted at approximately 20 U.S. centers found that patients who received Lamictal experienced a significant reduction in partial seizure frequency.
 Adverse reactions were generally mild and resolved without counter- measures or discontinuation of Lamictal. They included neurological side effects common in this population such as dizziness and double vision as well as headache, nausea and rash.
 Epilepsy is a chronic disorder of the nervous system brought on by excessive electrical stimulation of the brain which can result in recurrent seizures. The condition affects more than 2 million people in the United States, and each year about 125,000 new cases are diagnosed.
 It has been almost 15 years since a new antiepileptic drug was introduced in the United States. Although many epilepsy patients are able to successfully control their seizures through current antiepileptic drugs, as many as 45 percent of patients with partial epilepsy experience seizures despite therapy. In addition, many of the current medications have side effects that are problematic for patients and limit their clinical usefulness. Since Lamictal does not alter the blood concentrations of the most commonly used anti-epileptic drugs, it can be easily added to existing regimens.
 "There is a need to provide epilepsy patients who experience seizures not adequately controlled by current antiepileptic drugs with additional therapies," said Dr. Richard Kent, vice president of medical affairs at Burroughs Wellcome Co. "We believe that Lamictal will play an important role in reducing seizures and improving the quality of life for these patients."
 Lamictal is currently licensed as add-on therapy for patients with refractory partial seizures in 10 countries including Ireland and the United Kingdom.
 In addition to Lamictal, Burroughs Wellcome Co. is actively pursuing further developments in the field of central nervous system therapy including stroke and other conditions related to the brain's neurotransmitter system.
 -0- 3/20/93
 /CONTACT: Mari Toth, 919-248-8544, or Kathy Bartlett, 919-248-4302, both of Burroughs Wellcome Co./


CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU:

SB -- NYSA002 -- 8172 03/20/93 18:33 EST
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Date:Mar 20, 1993
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