To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Azulfidine EN-Tabs for Rheumatoid Arthritis Receives FDA Clearance URL: http://www.pslgroup.com/dg/D0F6.htm Doctor's Guide October 21, 1996
KALAMAZOO, Mich., Oct. 21, 1996 -- Pharmacia & Upjohn (NYSE: PNU) announced today that it has received U.S. Food and Drug Administration clearance to market Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP) for the treatment of rheumatoid arthritis (RA) in patients who have responded inadequately to or are intolerant of analgesics or other non-steroidal anti-inflammatory drugs (NSAIDs). Azulfidine EN-tabs are enteric-coated to reduce stomach absorption and minimize gastrointestinal irritation. Azulfidine EN-tabs, which are already available for the treatment of RA in 43 countries including the United Kingdom, Canada, Germany, Sweden and France, have been available in the U.S. for more than 20 years for the treatment and/or prolonged remission of ulcerative colitis. "Until recently, drugs used as second-line therapy were the last resort for treatment of advanced rheumatoid arthritis," said Roger Garceau, M.D., director of anti-inflammatory products and women's health, Pharmacia & Upjohn. Today, these second-line drugs have a more significant treatment role. Azulfidine EN-tabs have been shown to be effective and generally well-tolerated when used in combination therapy with salicylates or other NSAIDs. Rheumatoid arthritis, one of the more common forms of arthritis, is a chronic, systemic, inflammatory autoimmune disorder of unknown etiology. RA causes inflammation in the lining of the joints and other internal organs; destruction of cartilage, bone, tendons and ligaments can follow. It affects approximately 1 percent of the U.S. population (2.5 million) and results in more than 9 million physician visits and 250,000 hospitalizations per year. Disease onset occurs most often between the ages of 40 and 60 with 91 percent of patients older than 40. More than 60 percent of RA patients are women. With Americans living longer, RA is an important medical condition that is growing in magnitude. According to 1996 clinical guidelines issued by the American College of Rheumatology (ACR), patients with active RA have a 70 percent probability of developing joint damage or erosions within two years of disease onset. While NSAIDs are a common first step in alleviating symptoms of RA, joint damage may occur and progress. Therefore, many patients will require second-line therapy if response to salicylates and other non-steroidal anti-inflammatory drugs is inadequate. In clinical trials, the effects of Azulfidine EN-tabs were measured by the degree of improvement in the number and extent of actively inflamed joints. Patient response to Azulfidine EN-tabs in clinical trials were observed in some patients as early as four weeks after starting treatment, but 12 weeks may be required in some patients before clinical benefit is noted. Available by prescription only, Azulfidine EN-tabs are administered daily in evenly divided doses (2-3) totaling 2 grams and are recommended for use in concurrent treatment with analgesics and/or other NSAIDs, at least until effects are apparent. The most common adverse reactions associated with Azulfidine EN-tabs are anorexia, headache, nausea, vomiting, gastric distress and reversible low sperm count. These side effects occur in one-third of patients. Additionally, skin rash was reported by 13 percent of patients in RA trials. The medication is contraindicated in pediatric patients under two years of age, patients with intestinal or urinary obstruction, patients with porphyria (group of disorders associated with a lack of porphyins) and patients hypersensitive to sulfasalazine, its metabolites, sulfonamides or salicylates. Complete blood counts and urinalysis should be done frequently in patients taking Azulfidine EN-tabs. Pharmacia & Upjohn, Inc., is a research-based pharmaceutically focused company dedicated to helping people around the world live longer and fuller lives. The Company was formed through a merger of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn is a provider of human health care and related products, and operates on a global basis. The Company has a corporate management center in London and major research and manufacturing centers in the United States, Sweden and Italy. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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