AstraZeneca, Pozen Get FDA Approval for Vimovo

AstraZeneca and Pozen, Inc. received approval from the FDA for Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. Vimovo is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI).

The approval was based on clinical data which showed that patients taking Vimovo experienced significantly fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.

“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,” said Howard Hutchinson, M.D., chief medical officer, AZ. “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.”