Aspirin therapy is widely accepted as a preventative treatment for secondary cardiovascular events. Current regulatory guidelines even recognize the medication’s role in primary prevention. But while effective, gastrointestinal issues in some patients often make a daily aspirin regimen difficult to maintain.
Aralez Pharmaceuticals, a global specialty drug-maker headquartered in Ontario, Canada, announced Sept. 15 that it has received approval from the FDA for the drug YOSPRALA. A combination of aspirin, an anti-platelet agent and the proton-pump inhibitor omeprazole, the drug is intended to reduce the risk of gastric ulcers in patients on a daily aspirin regimen.
The drug works in two stages. It immediately releases omeprazole to reduce excess stomach acid. The enteric-coated aspirin dissolves after the stomach’s pH has been elevated above 5.5, which is approaching neutral on the pH scale. This reduces the risk of stomach ulcers.
“The approval of YOSPRALA marks a major achievement for Aralez and helps address the current public health dilemma around patient discontinuation of daily aspirin therapy, which has potentially serious consequences.” Adrian Adams, CEO of Aralez, said in a statement.
A Harvard Medical School study found that patients who are at an increased risk of cardiovascular disease and stop an aspirin regimen are three times as likely to have major cardiac event.
According to the Mayo Clinic, up to 26.2 million adults in the U.S. are at risk for secondary cardiovascular events. Drugs such as YOSPRALA help ensure that a greater percentage of this population will be able to adhere to an aspirin regimen that has been proven to reduce the likelihood of cardiac events.