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ZOFRAN TABLETS FOR CANCER CHEMOTHERAPY-INDUCED EMESIS AVAILABLE BY PRESCRIPTION IN THE UNITED STATES

 NEW YORK, April 28 /PRNewswire/ -- Cerenex Pharmaceuticals, a Division of Glaxo Inc., announced today that ZOFRAN (ondansetron HCl) Tablets, the first 5-HT3 antagonist available in oral form for the prevention of nausea and vomiting (emesis) in cancer patients receiving moderately emetogenic chemotherapy, are now available for prescription. ZOFRAN was first introduced as an intravenous antiemetic therapy in 1991 and has rapidly become accepted in oncology units nationwide.
 "Approved last December, ZOFRAN Tablets represent a useful and significant therapeutic option for cancer patients, physicians and oncology nurses," said Kelly Pendergrass, M.D., a specialist in oncology located in Kansas City, Mo. "By adding the convenience of oral dosing to the proven efficacy and safety profile of ZOFRAN, patients may be able to continue their treatments in the comfort of their homes," Pendergrass added.
 Two double-blind placebo-controlled clinical trials of ZOFRAN Tablets were conducted in the United States. These studies included 304 patients and demonstrated that ZOFRAN effectively blocks nausea and vomiting induced by cyclophosphamide-based chemotherapy containing either methotrexate or doxorubicin, common chemotherapy agents used in treatment of a variety of cancer types, including breast cancer, non- Hodgkin's lymphoma (NHL) and lung cancer.
 "The studies clearly demonstrate that the oral formulation of ZOFRAN is well tolerated, effective and has a favorable safety profile," explained James H. Lewis, M.D., Vice President of Medical Development- Marketed Products, Glaxo Inc. "The most common side effect is mild to moderate headache treatable with over-the-counter medications. There have been rare reports consistent with, but not diagnostic of extrapyramidal reactions (extreme restlessness and muscle spasms) in patients receiving ondansetron. ZOFRAN Tablets will be supplied in 8mg tablets for adults and 4mg tablets for pediatric oncology patients," he added.
 Ondansetron selectively blocks the serotonin (subtype 5-HT3) receptor sites that are believed to mediate chemotherapy-induced emesis. Emesis is a natural protective mechanism by which the body expels noxious material from the gastrointestinal (GI) tract. Emesis is a reflex that can be initiated by stimulation at a number of places in the body; two important sites being in the GI tract and the chemoreceptor trigger zone (CTZ) in the brain.
 It is suggested that chemotherapy causes emesis by triggering the release of large amounts of 5-hydroxytryptamine (5-HT, or serotonin). Serotonin molecules bind to and activate 5-HT3 receptors on endings located on the vagus nerve in the gut. Once stimulated, the vagus nerve carries impulses to the CTZ in the brain. The CTZ sends impulses to the vomiting center which initiates the movement of abdominal and respiratory muscles that cause nausea and vomiting.
 Clinical studies show that as many as 80 percent of cancer patients can be affected by emesis. Emesis can take different forms; acute emesis occurs in the 24-hour period immediately following chemotherapy,


and it usually begins one and one-half to two hours after treatment; or it can occur 9-12 hours after chemotherapy, which is referred to as late onset of acute emesis; delayed emesis can occur after the first 24 hours and can last several days. Uncontrolled, it can lead to dehydration and other salt imbalances. ZOFRAN Tablets have proven effective for many patients suffering from acute emesis. It is thought that ZOFRAN prevents emesis by preventing 5-HT from binding to the 5-HT3 receptors in the gut and in the brain.
 Glaxo Inc., researches, develops, manufactures and markets prescription medicines, including those for the treatment of gastrointestinal disorders, central nervous system disorders, respiratory disorders, cardiovascular diseases, infectious diseases and diseases of the skin. It is a subsidiary of Glaxo Holdings p.l.c. (NYSE: GLN) in the United Kingdom.
 -0- 4/28/93
 /NOTE: ZOFRAN is a registered trademark.
 A package insert outlining prescribing information is available from the contact below./
 /CONTACT: Rick Sluder of Cerenex Pharmaceuticals, 919-248-2839/
 (GLN)


CO: Cerenex Pharmaceuticals ST: New York IN: MTC SU: PDT

IH-DS -- DC001 -- 1867 04/28/93 10:02 EDT
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Date:Apr 28, 1993
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