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FDA APPROVES SMITHKLINE BEECHAM'S PAXIL FOR U.S. MARKETING FOR THE TREATMENT OF DEPRESSION

 PHILADELPHIA, Dec. 30 /PRNewswire/ -- SmithKline Beecham (NYSE: SBH) has received approval from the U.S. Food and Drug Administration (FDA) to market Paxil (paroxetine hydrochloride), a selective serotonin reuptake inhibitor (SSRI), for the treatment of depression.
 "Paxil provides unsurpassed control of depression, and -- importantly -- has been shown to be effective in maintaining antidepressant response for periods of up to one year," said Dr. Jean- Pierre Garnier, president, SmithKline Beecham Pharmaceuticals-North America.
 Paxil received marketing approval just 12 weeks after an advisory committee to the FDA voted unanimously that data from worldwide clinical trials demonstrated the drug is safe and effective in the treatment of depression. In addition, Paxil was shown to be effective for the prevention of relapse during long-term treatment.
 Over 6,700 patients were involved in worldwide clinical trials that established the safety and effectiveness of Paxil in the treatment of depression. In the clinical trials program, the drug was used in a broad range of depressed patients, including the moderately to severely depressed, the elderly, and patients whose depressions were accompanied by symptoms of anxiety. In these studies, Paxil also was shown effective in improving certain symptoms such as sleep disturbances and anxiety that frequently are associated with depression.
 Paxil has been shown to have efficacy comparable to traditional antidepressants (such as the tricyclic agent imipramine); however, Paxil has a more favorable safety profile and is more easily tolerated by patients. It has been shown to be equally well tolerated in the elderly and the younger adult population.
 Side effects associated with Paxil tend to be mild and transient. As with other SSRIs, nausea is the most common side effect reported by patients treated with Paxil; however, only three percent of patients discontinued therapy as a result of this effect.
 The dose regimen for Paxil is well defined. The recommended starting and usual dose for most patients is 20 mg taken once a day (usually in the morning).
 SmithKline Beecham Pharmaceuticals submitted a New Drug Application for Paxil to the FDA in November 1989. The product has been marketed in a number of countries, including the United Kingdom, Sweden, the Netherlands and Germany. Paxil will be available in 20 mg. scored tablets and 30 mg. tablets by prescription in early 1993.
 SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets human and animal pharmaceuticals, over-the-counter medicines, and clinical laboratory testing services.
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 /CONTACT: Jeremy Heymsfeld (media), 215-751-5166; Richard Williams (investor relations), 215-751-7002; or Alan Chandler (U.K. media), 081-975-2290; Philip Ward (U.K. investor relations), 081-975-2297, all of SmithKline Beecham/
 (SBH)


CO: SmithKline Beecham; U.S. Food and Drug Administration ST: Pennsylvania IN: MTC SU:

JS -- PH004 -- 0642 12/30/92 14:09 EST
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Date:Dec 30, 1992
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