AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration (FDA) has approved 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 NSAID-associated gastric ulcers. VIMOVO, co-developed by POZEN Inc. and AstraZeneca, is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). 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 significantly fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.
Twenty-seven million Americans are affected by osteoarthritis, which is the most common form of arthritis. While many patients with osteoarthritis treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of gastrointestinal ulcers.
"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," said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca. "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."
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 500 mg, 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 (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).
The most commonly observed adverse events in the clinical trials (experienced by >5% of patients in the VIMOVO group) were erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain and nausea.