Commercial Launch of Cardioprotective Drug Announced

Yosparla prevents secondary cardiovascular events while preventing aspirin-associated gastric ulcers.

Aralez Pharmaceuticals recently announced the commercial launch of the drug Yosprala in the United States. It is currently being promoted by over 100 sales representatives and is available in the wholesale market.

Yosprala is a fixed-dose combination of aspirin and omeprazole that has received FDA-approval for the treatment of patients who require aspirin to prevent secondary cardiovascular and cerebrovascular events with a risk of developing aspirin-associated gastric ulcers, according to a press release.

There are approximately 26.2 million adults in the United States at-risk of secondary cardiovascular events. Preventing these events is important for patients with heart disease.

Daily aspirin is the recommended prevention treatment, but it can cause gastrointestinal symptoms, including gastric ulcers and bleeding, according to Aralez. Even low-dose, buffered, and enteric-coated aspirin can cause these issues; however, proton pump inhibitors, such as omeprazole, may offer gastroprotection.

Yosprala offers protection through the Intelli-COAT, which delivers 40 mg of omeprazole, followed by an extended-release dose of enteric-coated aspirin. This delivery method protects the patient’s stomach from ulcers.

The aspirin portion of the drug is able reduce the combined risk of death and nonfatal stroke in patients who have has an ischemic stroke or transient ischemia of the brain from fibrin platelet emboli, Aralez wrote. It can also reduce the risk of death and nonfatal myocardial infarction who have previously had a myocardial infarction or unstable angina pectoris, and reduces the risk of myocardial infarction and death in patients with chronic stable angina pectoris.

Patients who underwent revascularization procedures can also benefit from Yosprala. The drug should not be used as initial aspirin therapy during the onset of acute coronary syndrome, acute myocardial infarction, or before percutaneous coronary intervention, according to the press release.

Yosprala has not been shown to reduce aspirin-related gastrointestinal bleeding. The drug should also not be stopped suddenly because it can increase the risk of having a heart attack or stroke.

The drug may cause liver or kidney problems, Clostridium difficile infections in the intestines, or lupus erythematosus. A recent study also found that long-term use of proton pump inhibitors can cause kidney damage, and should not be used for extended periods of time.

Yosprala can also cause low levels of B12 and magnesium, according to Aralez.

More common side effects include indigestion, heartburn, stomach pain, nausea, diarrhea, polyps in the stomach, and chest pains.

Aralez warns the Yosprala is not interchangeable with its components, aspirin and omeprazole.

“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, payors 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.”