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FDA APPROVES SMITHKLINE BEECHAM'S KYTRIL INJECTION

 PHILADELPHIA, Dec. 30 /PRNewswire/ -- SmithKline Beecham (SB) has received approval from the US Food and Drug Administration to market Kytril (granisetron hydrochloride) Injection for the prevention of nausea and vomiting associated with emetogenic cancer therapy.
 Kytril Injection was approved as single-dose, first-line therapy for the prevention of nausea and vomiting caused by either initial or repeat courses of cancer chemotherapy. The approval covers use of the product in cancer patients of all ages, including children and the elderly.
 Kytril Injection is a member of a new class of antinauseant and antiemetic drugs called 5-HT3-receptor antagonists. SB scientists laid the foundation for this drug class when they established that antagonism, or blocking, of 5-HT3 receptors played an important role in preventing nausea and vomiting induced by cancer chemotherapy. The blocking action of 5-HT3-receptor antagonists exerts this protective effect by preventing serotonin, a substance released in response to toxins including cancer drugs, from stimulating 5-HT3 receptors to trigger the vomiting reflex.
 Kytril Injection has been shown to provide protection against chemotherapeutic agents, including such highly emetogenic drugs as cisplatin, throughout the acute phase of nausea and vomiting, a period of about 24 hours. As with other 5-HT3-receptor antagonists, the most common side effect is headache.
 "Before the advent of the 5-HT3-receptor antagonists, patients ranked nausea and vomiting as the most distressing side effects of cancer therapy," said Dr. Jerry Karabelas, president, SmithKline Beecham Pharmaceuticals-North America. "Kytril provides physicians with a potent agent to help improve quality of life for patients while maintaining the rigorous therapy needed to combat cancer."
 SB plans to introduce Kytril Injection in the US in 1994. Currently, Kytril Injection is marketed in more than 30 countries, including most major European countries and Japan.
 SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets human and animal pharmaceuticals, over-the-counter medicines, consumer healthcare products, and clinical laboratory services.
 /delval/
 -0- 12/30/93
 /CONTACT: Richard Koenig of SmithKline Beecham, 215-751-3415/
 (SBH)


CO: SmithKline Beecham ST: Pennsylvania IN: MTC SU:

JM -- PH002 -- 7979 12/30/93 09:01 EST
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Publication:PR Newswire
Date:Dec 30, 1993
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