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FDA Approves Naproxen/Esomeprazole for Patients With Arthritis at Risk of Developing Gastric Ulcers NEW YORK -- May 3, 2010 -- The US Food and Drug Administration (FDA) has approved naproxen/esomeprazole (Vimovo) fixed-dose combination delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflammatory drug-associated gastric ulcers. The approval was based on data from a clinical development program and results from the PN400-301 and PN400-302 studies. In both studies, the primary end point was the cumulative incidence of gastric ulcers through 6 months. In each of the trials, patients received either naproxen/esomeprazole or enteric-coated naproxen 500 mg BID over a 6-month treatment period. Endoscopies were performed at baseline and at 1, 3, and 6 months. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking naproxen/esomeprazole, compared with 23.1% among patients taking enteric-coated naproxen (P < .001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking naproxen/esomeprazole, compared with 24.3% of patients taking enteric-coated naproxen (P < .001). The most commonly observed adverse events (experienced by >5% of patients in the naproxen/esomeprazole group) were erosive gastritis, dyspepsia, gastritis, diarrhoea, gastric ulcer, upper abdominal pain, and nausea. SOURCE: AstraZeneca E-mail this page to a friend or colleague! To print, use this version