AstraZeneca and Pozen Release Data on Osteoarthritis Drug

AstraZeneca and Pozen have announced pivotal data from two clinical trials. The data demonstrated that patients that were at risk for developing Non-Steroidal Anti-Inflammatory Drug (NSAID)-associated gastric ulcers taking Vimovo (naproxen/esomeprazole magnesium, formerly known as PN 400) experienced significantly fewer endoscopically confirmed gastric ulcers (GU) compared with patients taking enteric-coated (EC) naproxen (500 mg) alone.

Data from study PN400-301 showed a 4.1 percent incidence of GU in patients taking Vimovo, compared to 23.1 percent among patients taking EC naproxen (p<0.001). Study PN400-302 showed a 7.1 percent incidence of GU among patients taking Vimovo, compared to 24.3 percent with EC naproxen (p<0.001).

Marc C. Hochberg, professor of medicine and head of the Division of Rheumatology and Clinical Immunology, University of Maryland School of Medicine in Baltimore, and co-principal investigator for the study said, “If approved, Vimovo will provide arthritis patients at risk for NSAID-associated gastric ulcers a treatment option that combines enteric-coated naproxen and immediate release esomeprazole in a single pill.”

Studies 301 and 302 also analyzed the reduction in incidence of endoscopically confirmed GU among patients taking the drug and enteric coated naproxen who were on concomitant Low-Dose Aspirin (LDA) therapy.

Additional analyses examined the incidence of endoscopically confirmed duodenal ulcers (DU) among patients taking Vimovo.