The FDA has approved Vimovo (naproxen and esomeprazole magnesium delayed-release tablets, from AstraZeneca and POZEN) for the relief of the 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 NSAID-associated gastric ulcers.

This approval was based on results from the six-month PN400-301 and PN400-302 studies. Data from study PN400-301 showed a 4.1% incidence of gastric ulcers in patients taking VIMOVO, compared to 23.1% among patients taking enteric-coated naproxen (p<0.001). Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking Vimovo, compared to 24.3% with enteric-coated naproxen (p<0.001).

Vimovo is expected to be made available during summer 2010.

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