FDA Approves First 24-Hour Extended-Release Aspirin

Cardiovascular patients are the focus of the recent drug approval by the Food and Drug Administration (FDA). Branded under the name Durlaza, the 24-hour extended-release aspirin is the first of its kind and is expected to become available before the end of the year.

Durlaza (162.5mg) is designed for secondary prevention in patients with a high risk of cardiovascular events, including stroke and heart attack. The pharmaceuticals company New Haven Pharmaceuticals, Inc. developed the drug and announced its approval on September 8.

Previous studies have shown that low-dose aspirin can help prevent cardiovascular events, such as venous thromboembolism (VTE), by inhibiting platelet aggregation, or blood clotting. Durlaza, however, is the only 24-hour extended-release version of low-dose aspirin. The extended release property is important because while traditional aspirin typical stays in the blood for four to six hours, Durlaza prolongs the release for one day which results in sustained platelet exposure.

“Also, as one dosage form of any medication rarely works for all patients, Durlaza provides an alternative dosing option for patients who need aspirin for cardiovascular risk prevention,” Paul Gurbel, MD, associate chief for research and director of the Sinai Center for Thrombosis Research, said in the statement.

The CEO of New Haven Pharmaceuticals, Patrick Fourteau, confirmed that the drug should become available by prescription in the United States in the fourth quarter of 2015. The makers warn that, like immediate-release aspirin, the drug could increase the risk of bleeding. For more specific warnings, adverse effects, and drug interactions, see the company’s news release.