Aralez announced that the Food and Drug Administration (FDA) has approved Yosprala (omeprazole and aspirin) to treat patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers. 

Yosprala combines aspirin, an antiplatelet, and omeprazole, a proton pump inhibitor (PPI). Its proprietary Intelli-COAT system allows sequential delivery of immediate-release omeprazole 40mg followed by a delayed-release, enteric-coated aspirin core (81mg or 325mg). The omeprazole component is designed to raise the gastric pH into a gastroprotective zone; the aspirin component dissolves after the pH rises to ≥5.5, reducing the risk of stomach ulcer. 

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The FDA approval was supported by data from two randomized, double-blind controlled trials where patients were randomized to receive either Yosprala 325mg/40mg (n=524) or enteric-coated aspirin 325mg (n=525). Each study met its individual primary endpoint with patients in the Yosprala arm having significantly less endoscopic gastric ulcers compared to those taking enteric-coated aspirin alone. Also, significantly less patients treated with Yosprala stopped therapy due to prespecified upper gastrointestinal adverse events vs. patients treated with enteric-coated aspirin. 

Yosprala is not interchangeable with the separate components of aspirin and omeprazole. The product is expected to launch in the first week of October as 81mg/40mg and 325mg/40mg strength tablets.

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