FDA Approves New Option for Secondary CV Prevention

The FDA has approved Yosprala—a combination of aspirin and omeprazole, a proton pump inhibitor—for the treatment of patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events but who are at risk of developing aspirin-associated gastric ulcers.

The drug is formulated to deliver immediate-release omeprazole—which alleviates gastric pH—followed by delayed-release aspirin in order to remain cardio- and gastro-protective.
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The approval of Yosprala is based on the results of 2 randomized, double-blind, controlled trials in which patients were randomly assigned to either Yosprala 325 mg/40 mg or to 325 mg of enteric-coated aspirin. Patients taking Yosprala experienced fewer endoscopic gastric ulcers compared to those taking aspirin alone, and significantly fewer patients taking the drug discontinued treatment due to adverse events.

The most common adverse reactions reported were gastritis, nausea, diarrhea, gastric polyps, and non-cardiac chest pain.

—Michael Potts

Reference:

Aralez Pharmaceuticals Inc. Aralez announces fda approval of Yosprala for secondary prevention of cardiovascular and cerebrovascular events in patients at risk for aspirin-associated gastric ulcers [press release]. September 15, 2016. http://www.prnewswire.com/news-releases/aralez-announces-fda-approval-of-yosprala-for-secondary-prevention-of-cardiovascular-and-cerebrovascular-events-in-patients-at-risk-for-aspirin-associated-gastric-ulcers-300328751.html.