Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced the availability of once-daily Yosprala, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), in the US. 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 being promoted by 110 sales representatives in the US and is currently available in the wholesale chain.

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.

"We are pleased to announce the commercial launch of Yosprala in the US supported by our fully trained, 110 person sales force deployed to promote Yosprala to cardiologists and high prescribing primary care physicians," said Adrian Adams, chief executive officer of Aralez. "Yosprala, a product that is specifically designed to reduce aspirin intolerance and therefore potentially improve compliance to therapy, has the promise to benefit healthcare practitioners, payers and patients. We believe that Yosprala represents a significant market opportunity and will contribute to solidifying our core therapeutic anchor position in cardiovascular disease alongside Fibricor."

Up to an estimated 26.2 million adults in the US are at risk for secondary CV events. The occurrence of secondary CV events among people with heart disease continues to be a significant problem in the US. Patients who have experienced a heart attack have an elevated CV risk within the first six years of that first event, equating to an estimated 200,000 Americans a year who go on to have a second heart attack.

Recent guidelines from the American College of Cardiology and American Heart Association affirm the importance of daily aspirin therapy. Daily aspirin therapy, however, can cause gastrointestinal symptoms and damage, such as gastroesophageal reflux disease, gastric ulcers and even gastrointestinal bleeding, through both direct and indirect mechanisms.

A 2008 Expert Consensus Task Force specifically examined ways to reduce the gastrointestinal risks of antiplatelet therapy and nonsteroidal anti-inflammatory drugs (NSAID) use including aspirin. The findings included data which demonstrated that gastrointestinal risk may occur regardless of aspirin dose or formulation, meaning low-dose, buffered and enteric-coated aspirin preparations may not be gastro protective. The Task Force also devised an algorithm for the prevention and treatment of aspirin and NSAID-related gastroduodenal injury. PPI therapy is believed to reduce the risk in all patients and was a proposed strategy for gastroprotection.

Yosprala is a combination of enteric-aspirin (81 mg or 325 mg), an anti-platelet agent, surrounded by immediate-release omeprazole (40 mg), a proton pump inhibitor, indicated for patients who require aspirin for secondary prevention of CV and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.

The aspirin component of Yosprala is indicated for reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; reducing the combined risk of death and nonfatal myocardial infarction (MI) in patients with a previous MI or unstable angina pectoris; and reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris. It is also indicated for use in patients who have undergone revascularization procedures - coronary artery bypass graft or percutaneous transluminal coronary angioplasty - when there is a pre-existing condition for which aspirin is already indicated.

The omeprazole component of Yosprala is indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (= 55) or documented history of gastric ulcers.

Yosprala is not for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute MI or before percutaneous coronary intervention. Yosprala was evaluated in clinical studies for the reduction of gastric ulcers. It was not evaluated for the reduction of GI bleeding and therefore has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin. Yosprala is not interchangeable with the individual components of aspirin and omeprazole.