WILMINGTON, Del. The Food and Drug Administration has approved a drug by AstraZeneca and Pozen for treating arthritis patients at risk of developing ulcers in their digestive systems, AstraZeneca said Friday.
The FDA approved Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets. Naproxen is a pain reliever for signs and symptoms of rheumatoid arthritis, ostheoarthritis and ankylosing spondylitis, while the esomeprazole magnesium is a proton-pump inhibitor for preventing the development of ulcers. Around 50% of chronic users of nonsteroidal anti-inflammatory drugs, the drug class to which naproxen belongs, are at risk of developing gastrointestinal ulcers.
“In a single pill, Vimovo provides a proven pain reliever with a built-in PPI for arthritis patients at risk for NSAID-associated gastric ulcers,” AstraZeneca chief medical officer Howard Hutchinson said. “The approval also demonstrates the commitment of AstraZeneca and Pozen to provide a new pain-relief option that addresses the unmet medical needs of these patients.”