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.”