FDA accepts NDA for Pozen’s Vimovo

CHAPEL HILL, N.C. The Food and Drug Administration has accepted the regulatory approval application for a drug designed to treat arthritis in patients prone to getting ulcers from their pain relievers.

Pozen announced Monday the FDA’s acceptance of its new drug application for Vimovo (naproxen and esomeprazole magnesium). The drug combines enteric-coated naproxen, a non-steroidal anti-inflammatory drug, or NSAID, with immediate-release esomeprazole, a proton pump inhibitor. It’s designed to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing gastric ulcers associated with NSAIDs.

Osteoarthritis affects nearly 27 million people in the United States, but half of them are at risk from developing ulcers from using NSAIDs to relieve their pain.

Pozen developed Vimovo under an agreement with Anglo-Swedish drug maker AstraZeneca, which will pay Pozen a $10 million milestone payment for the FDA’s acceptance of the application.