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FDA approved once-daily Yosprala (Aralez), a fixed-dose combination of aspirin, an anti-platelet agent and omeprazole, a proton pump inhibitor (PPI), 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.Here are the top 5 facts to know about Yosprala.
FDA approved a fixed-dose combination of aspirin, an antiplatelet agent, and omeprazole, a proton pump inhibitor (Yosprala, Aralez), 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.
"Daily aspirin is a standard of care for secondary cardiovascular event prevention, but gastrointestinal symptoms are often cited as the reason patients stop taking this important therapy. Discontinuation of daily aspirin therapy for secondary prevention can pose a significant cardiovascular risk," said Lori Mosca, MD, a national expert in cardiovascular disease prevention and education, said in a press release.
Here are the top 5 facts to know about Yosprala:
1. Yosprala will launch in October, supported by 110 sales reps.
2. Peak sales of the drug could exceed the $200 million guidance, according to Seeking Alpha. Up to an estimated 26.2 million adults in the United States are at risk for secondary CV events. Patients who have experienced a heart attack have an elevated CV risk within the first 6 years of that first event, equating to an estimated 200,000 Americans a year who go on to have a second heart attack, according to Aralez.
3. Yosprala is designed to support both cardio- and gastro-protection for at-risk patients through its proprietary Intelli-COAT system, 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 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 greater than 5.5, within the gastroprotective zone, thereby reducing stomach ulcer risk.
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4. FDA’s approval of Yosprala was based on the results from 2 randomized, double-blind controlled clinical trials that patients were randomly assigned to receive either Yosprala 325 mg/40 mg or 325 mg of enteric-coated aspirin. Each study achieved its individual primary end point 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 pre-specified upper gastrointestinal adverse events compared to patients in the enteric-coated (EC) 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.