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news.AstraZeneca and Pozen have received FDA approval for Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of 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 non-steroidal anti-inflammatory drugs (NSAID) associated gastric ulcers.
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Vimovo, co-developed by Pozen and AstraZeneca, is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor (PPI).
Reportedly, the FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking Vimovo experienced fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.
Additionally, in the PN400-301 and 302 studies, the primary end point was the cumulative incidence of gastric ulcers through six months. In each of the trials, patients received either Vimovo or enteric-coated naproxen 500mg, twice daily, over a six-month treatment period. Endoscopies were performed at baseline and at one, three, and six months.
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. Study PN400-302 showed a 7.1% incidence of gastric ulcers among patients taking Vimovo, compared to 24.3% with enteric-coated naproxen.
Howard Hutchinson, chief medical officer of AstraZeneca, said: “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.
“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.”