The Food and Drug Administration has approved the aspirin/omeprazole combination drug Yosprala for patients who seek to prevent secondary cardiovascular events but who avoid aspirin because of their risk for gastric ulcers. The approval was announced in a press release Sept. 15 from Aralez Pharmaceuticals.
The medication contains 40 mg of immediate-release omeprazole and either 81 mg or 325 mg of aspirin in an enteric-coated core for delayed release. The immediate-release omeprazole “is designed to elevate the gastric pH into a gastroprotective zone,” according to the company. “The enteric-coated aspirin dissolves after the pH has been elevated to at least 5.5 within the gastroprotective zone, thereby reducing stomach ulcer risk.”
The approval is based on data from a pair of randomized, double-blind, controlled trials. In these studies, patients at risk for gastric ulcers were significantly less likely to report ulcers and significantly less likely to discontinue the medication than were controls who received aspirin alone. Side effects were not significantly different between the groups; the most common side effects were indigestion, stomach pain, nausea, diarrhea, gastric polyps, and chest pain.
The studies did not examine whether the medication had an impact on the risk of GI bleeding. The drug is not approved for use in children.