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efficacy Joint Meeting of the Arthritis and Drug Safety and Risk Management Advisory Committees February 16-18, 2005 Leonard M. Baum, RPh Vice President, Regulatory Affairs Bayer HealthCare Consumer Care Division Agenda Regulatory Overview Naproxen ADAPT Trial Safety Evaluation Clinical Pharmacology Clinical Studies Postmarketing Surveillance Observational Studies Conclusions Roche/Bayer Presenters and Responders Presenters: Leonard M. Baum, RPh Vice President, Regulatory Affairs Bayer HealthCare Martin H. Huber, M.D. Vice President, Global Head Drug Safety Risk Management Hoffmann La-Roche Inc. Responders: Susan Sacks, Ph.D. Global Head, Epidemiology Hoffmann La-Roche Inc. Bharat Thakrar, Ph.D. Senior Epidemiologist Hoffmann La-Roche Inc. Outside Experts Kay Brune, M.D. Professor and Chairman Department of Experimental and Clinical Pharmacology and Toxicology Friedrich-Alexander University Erlangen - Nuremberg Ian M. Gralnek, M.D., MSHS Assistant Professor of Medicine, Division of Digestive Diseases David Geffen School of Medicine at UCLA Regulatory Overview Naproxen available in the United States since 1976 Prescription currently marketed by multiple manufacturers for the treatment of RA, OA, ankylosing spondylitis, gout, juvenile RA, dysmenorrhea, tendinitis, bursitis, and pain Aleve (OTC) approved in 1994 Currently marketed by Bayer HealthCare for temporary relief of minor aches and pains, and for the temporary reduction of fever Multiple generic versions Naproxen Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), belongs to the chemical class propionic acid derivatives Naproxen has anti-inflammatory, analgesic and antipyretic properties Naproxen known to inhibit platelet aggregation The major differences between members of the NSAID class are potency and pharmacokinetics Classes of NSAIDS Salicylic acid derivatives Aspirin, sodium salicylate, choline magnesium trisalicylate, salsalate, diflunisal Para-aminophenol derivatives Acetaminoph