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 RESEARCH TRIANGLE PARK, N.C., Aug. 17 /PRNewswire/ -- Glaxo Inc. announced today that it received clearance from the Food and Drug Administration (FDA) to market ZOFRAN (ondansetron HCl) Injection for a new indication, the prevention of postoperative nausea and vomiting (PONV), at a dose of 4 mg. ZOFRAN Injection is the first 5-HT3 antagonist available for the prevention of PONV. ZOFRAN Injection was introduced in 1991 for the prevention of nausea and vomiting (emesis) in cancer patients receiving chemotherapy.
 Estimates indicate that despite standard therapies, about 30 percent of patients undergoing the more than 23 million surgical procedures performed in the U.S. each year still experience nausea and vomiting. PONV is caused by many stimuli and varies in both severity and duration. While PONV is frequently a side effect of some anesthetics used prior to or during surgery, both the type of surgery and certain patient characteristics are also linked to an increased risk of PONV. For example, an increased risk of emesis has been associated with abdominal, gynecological and ophthalmic surgery; and with gender (female), age, people who are overweight and those with a previous history of PONV or motion sickness.
 "PONV is a common problem after ambulatory surgery, with potentially serious medical complications, which may delay discharge from the hospital and result in unanticipated hospitalizations," said Paul F. White, M.D., Ph.D., Professor and McDermott Chair of Anesthesiology, Southwestern Medical Center, University of Texas. "Aside from the obvious discomfort and inconvenience it causes patients, PONV, in rare instances, can lead to dehydration and ruptures of the surgical wound," Dr. White continued.
 Reduction in the incidence of PONV will become a greater priority, as it is estimated that by 1995, outpatient surgery will account for over 50 percent of the projected 29.5 million operations in the U.S.
 ZOFRAN Injection has been studied in more than 2,800 surgical patients worldwide in clinical trials for the prevention of PONV. ZOFRAN Injection was given to patients prior to surgery and to patients who experienced nausea and vomiting postoperatively. ZOFRAN Injection is superior to placebo in anti-emetic efficacy and is well tolerated. The most common side effect is mild to moderate headache, with an incidence rate similar to placebo. Studies show that a single dose effectively prevented emesis in a significant number of patients over 24 hours. Currently available anti-emetic therapies for PONV can leave patients sedated, while the incidence of sedation for ZOFRAN Injection was similar to placebo. Researchers believe that ZOFRAN Injection prevents emesis by selectively blocking the neurotransmitter 5-hydroxytryptamine (5-HT, or serotonin) from binding to 5-HT3 receptors. Emesis is a natural protective mechanism by which the body expels noxious and/or toxic material in response to stimuli from the gastrointestinal tract and the brain. The emetic reflex may be activated by drugs or by the release of substances in the body following tissue damage.
 Initial emesis research focused on chemotherapy-induced emesis caused by
chemotherapeutic drugs designed to kill cancer cells. Like chemotherapy-induced emesis, PONV is also believed to involve serotonin release and 5-HT3 receptor blockade.
 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: GLX) in the United Kingdom.
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 /NOTE TO EDITORS: ZOFRAN is a registered trademark. A package insert and outlining prescribing information is available from the contact below.
 Opportunity to be briefed by experts on postoperative nausea and vomiting: Two prominent experts on PONV, Paul F. White, M.D., Ph.D., Professor and McDermott Chair of Anesthesiology of Southwestern Medical Center, University of Texas, and Jeffrey L. Apfelbaum, president, Society for Ambulatory Anesthesia, will provide information on PONV to the media via a telephone briefing on Aug. 26, at 9:30 a.m. Call Bob Schwadron at 212-626-6554 or Kara McCollum at 202-973-0366 to reserve your space./
 /CONTACT: Nancy Pekarek of Glaxo, 919-248-2839/

CO: Glaxo Inc.; Food and Drug Administration ST: North Carolina IN: MTC SU:

TW -- DC002 -- 3406 08/17/93 08:52 EDT
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Publication:PR Newswire
Date:Aug 17, 1993
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