New Aspirin Formulation Nabs FDA Approval

The FDA has approved the first and only 24-hour aspirin formulation.

New Haven Pharmaceuticals’ 162.5 mg extended-release aspirin (Durlaza) is indicated for the secondary prevention of stroke and acute cardiac events such as myocardial infarction in high-risk patients.

While traditional immediate-release aspirin remains in the blood for only about 4 to 6 hours, Durlaza's extended-release capabilities allow for prolonged absorption and sustained platelet exposure to aspirin.

“The aspirin delivery technology in Durlaza extends the release of aspirin in a manner designed to provide a stable antiplatelet effect over the course of the day. The latter unique property of Durlaza is important as patients at risk generate new platelets throughout the day,” said Paul Gurbel, MD, associate chief for research and director of the Sinai Center for Thrombosis Research, in a press release. “...As 1 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.”

Previous research has demonstrated low-dose aspirin’s ability to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular disease.

Durlaza will be available by prescription in the fourth quarter of 2015, New Haven Pharmaceuticals CEO Patrick Fourteau said.

Like immediate-release aspirin, Durlaza use can increase the risk of bleeding and gastric ulceration, and it may cause fetal harm, increased incidence for intracranial hemorrhage in premature infants, stillbirths, and neonatal deaths when administered to pregnant women.