May 5, 2010 — The US Food and Drug Administration (FDA) has approved a fixed-dose tablet combination of delayed-release enteric-coated naproxen and immediate-release esomeprazole magnesium (Vimovo; AstraZeneca and Pozen, Inc).
The nonsteroidal anti-inflammatory drug (NSAID)/proton pump inhibitor combo is indicated to relieve signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis while decreasing the risk for NSAID-related gastric ulcers in susceptible patients.
Osteoarthritis, which affects approximately 27 million Americans, is commonly treated with NSAIDs such as naproxen. According to a company news release, as many as 50% of chronic NSAID users are at risk for gastrointestinal ulcers.
"In a single pill, Vimovo provides a proven pain reliever with a built-in [proton pump inhibitor] for arthritis patients at risk for NSAID-associated gastric ulcers," said Howard Hutchinson, MD, chief medical officer, AstraZeneca, in a company news release.
FDA approval was based on data from the pivotal PN400-301 and PN400-302 six-month studies, showing that twice-daily use of naproxen/esomeprazole delayed-release tablets yielded a decreased rate of endoscopic gastric ulcers compared with 500 mg enteric-coated naproxen given twice daily (4.1% vs 23.1% and 7.1% vs 24.3%, respectively; P < .001 for both studies).
Adverse events most commonly (>5%) reported with use of naproxen/esomeprazole included erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea.
Naproxen/esomeprazole therapy should not be used to treat perioperative pain in the setting of coronary artery bypass graft surgery. Use is likewise contraindicated in patients with known hypersensitivity to either component or substituted benzimidazoles; those with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs; patients with severe hepatic insufficiency; and women in the late stages of pregnancy.
Caution is advised when treating patients with fluid retention, heart failure, hypertension, renal or hepatic insufficiency, cardiovascular disease, and the elderly.
Naproxen/esomeprazole delayed-release tablets are currently under review by the European Medicines Association.