Aralez Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has approved once-daily YOSPRALA™, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the U.S. YOSPRALA is indicated for 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 is designed to support both cardio- and gastro-protection for at-risk patients through the proprietary Intelli-COAT™ system, which is formulated to sequentially deliver immediate-release omeprazole (40 mg) followed by a delayed-release, enteric-coated aspirin core in either 81 mg or 325 mg dose strengths. The YOSPRALA immediate-release omeprazole is designed to elevate the gastric pH into a gastroprotective zone. The enteric-coated aspirin dissolves after the pH has been elevated to = 5.5, within the gastroprotective zone, thereby reducing stomach ulcer risk. The FDA approval of YOSPRALA was based on the results from two randomized, double-blind controlled clinical trials that patients were randomly assigned to receive either YOSPRALA 325 mg/40 mg (n=524) or 325 mg of enteric-coated aspirin (n=525). Each study achieved its individual primary endpoint with patients in the YOSPRALA arm experiencing significantly fewer endoscopic gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. In addition, significantly fewer patients treated with YOSPRALA discontinued therapy because of prespecified upper gastrointestinal adverse events compared to patients in the enteric-coated aspirin (325 mg) arm.5 The most common adverse reactions reported in adults (incidence = 2% and greater than 325 mg EC aspirin) during the studies were gastritis, nausea, diarrhea, gastric polyps and non-cardiac chest pain.