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RELAFEN AVAILABLE IN THE UNITED STATES: NEW CLASS OF NSAID WITH LOW ULCER INCIDENCE

 RELAFEN AVAILABLE IN THE UNITED STATES:
 NEW CLASS OF NSAID WITH LOW ULCER INCIDENCE
 NEW YORK, March 19 /PRNewswire/ -- SmithKline Beecham announced today that Relafen(R) (nabumetone), the first of a new nonsteroidal anti-inflammatory drug (NSAID) class, is available though a doctor's prescription, in pharmacies across the United States. Relafen has been demonstrated to have efficacy comparable to that of other NSAIDs and a low incidence of upper gastrointestinal (GI) ulcers. Other gastrointestinal symptoms are comparable to other NSAIDs.
 Indicated for acute and chronic treatment of the signs and symptoms caused by osteoarthritis and rheumatoid arthritis, Relafen is the first of a new class of NSAID known as naphthylalkanones. It is the first nonacidic NSAID and the first NSAID prodrug -- that is, it does not become active as the acidic metabolite until after it passes through the stomach and is biotransformed by the liver. No parent compound appears in the plasma.
 Up to 74,000 cases of upper GI bleeding occurred as a result of NSAID use in the United States in 1990(A).
 The low incidence of ulcers with Relafen is reflected in the prescribing information, which indicates that "in controlled clinical trials, involving 1,677 patients treated with Relafen (1,140 followed for one year and 927 followed for two years), cumulative incidence of peptic ulcers was 0.3 percent at three to six months, 0.5 percent at one year, and 0.8 percent at two years." Other GI symptoms are comparable to those of other NSAIDs, including diarrhea (14 percent), dyspepsia (13 percent), and abdominal pain (12 percent).
 It is known that NSAIDs can cause upper GI ulcers and ulcer complications in some people. Upper gastrointestinal ulcers, which include those occurring in the stomach or duodenum, can lead to life- threatening complications, often without any symptoms or warning signs.
 A recent study demonstrates the magnitude of the problem. A review of the scientific literature and analysis of the most recent national hospitalization data reveal that GI ulcers are present in 14 percent to 31 percent of individuals regularly using NSAIDs(B). In addition, studies have shown that NSAID use is responsible for approximately 75 percent of all upper GI bleeding among individuals on regular, high-dose NSAID therapy -- such as people with arthritis(C)(D).
 "With Relafen, individuals with arthritis have available to them an effective NSAID with low incidence of ulcers," said Wilbur Blechman, M.D., clinical professor, University of Miami Medical School, Miami. "We have been looking for the answer to the classic arthritis treatment dilemma -- choosing among effective arthritis medicine with the risk of ulceration, less effective relief with lower ulcer risk, or co-medication to prevent or treat ulcers," Blechman added.
 Currently, there are more than 15 NSAIDs on the market. "With Relafen, the 13 million arthritis patients in the United States who count on these agents to be able to perform simple daily activities will have available to them an effective medication with a low incidence of ulcers," said Dr. J.P. Garnier, president, North America Pharmaceuticals, SmithKline Beecham.
 In conjunction with the introduction of Relafen, SmithKline Beecham will support the first community-wide effort to improve the lives of people with arthritis. The effort will take place in San Mateo, Calif. The goal of the San Mateo Arthritis Project is to create a national model for a community-based approach to overcoming low awareness and underutilization of arthritis resources and services.
 More tan five million prescriptions have been written for Relafen in more than 15 countries around the world, including Germany, the United Kingdom, and Japan. The efficacy and safety of nabumetone have been evaluated in postmarketing surveillance of more than 26,000 patients in West Germany and close to 11,000 patients in the United Kingdom. Experience with Relafen in the United States includes clinical trials studying more than 4,000 patients, some of whom took Relafen for eight years.
 At an estimated daily cost to the patient of $2.00, Relafen is priced competitively with other NSAIDs. The recommended starting dosage for Relafen is 1,000 mg, which can be given once-daily.
 SmithKline Beecham is a worldwide research-intensive health care company with 1991 sales of $8.7 billion and an annual research budget of more than $800 million. In addition to arthritis, SmithKline Beecham scientists focus on the discovery of drugs to treat infection, cardiovascular disease, central nervous system disorders, and gastrointestinal disease.
 (A) -- Kurata J, manuscript in preparation
 (B) -- Soll AH, Weinstein, WM, Kurata J, McCarthy D. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med 1991; 114:307-319.
 (C) -- Pincus T, Griffin M. Gastrointestinal disease associated with nonsteroidal anti-inflammatory drugs: New insights from observational studies and functional status questionnaires (editorial). Am J Med 1991;91:209-212.
 (D) -- Fries JF, Williams, CA, Block DA, Michel BA. Nonsteroidal anti-inflammatory drug-associated gastropathy: Incidence and risk factor
models. Am J Med 1991;91:213-222. -0- 3/19/92
 /CONTACT: Jeremy Heymsfeld, 215-751-5166, or Kathy Varjavandi, 212-704-8217, both of SmithKline Beecham/ CO: SmithKline Beecham ST: Pennsylvania IN: HEA SU:


TS -- NY004 -- 9522 03/19/92 09:02 EST
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Date:Mar 19, 1992
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