New aspirin formulation approved for secondary prevention of stroke, cardiac events

FDA has approved aspirin extended-release capsules (Durlaza, New Haven Pharmaceuticals, Inc.) for the prevention of stroke and acute cardiac events.

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Platelets-specialized cells present in the blood that are involved in the formation of blood clots-play a key role in heart attacks, strokes, and peripheral vascular disease. Because of its ability to inhibit platelet aggregation, low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events, including stroke and heart attack. While the body is constantly producing platelets 24 hours a day, current immediate-release aspirin has a duration of action of only 4 to 6 hours with a peak concentration after about 30 minutes.

Durlaza is the first, and only 24-hour, extended-release aspirin capsule. The extended-release microcapsule technology allows prolonged absorption and sustained platelet exposure to aspirin. It is indicated to reduce the risk of death and myocardial infarction (MI) in patient with chronic coronary artery disease, including patients with a history of MI or unstable as well as chronic angina. It is also approved to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

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"Durlaza is an aspirin formulation for secondary prevention in high-risk CVD patients. 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. 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, Sinai Hospital, Baltimore, professor of medicine, Johns Hopkins University, adjunct professor of medicine, Duke University, said in a press release.

Immediate-release aspirin, not Durlaza, should be used in situations where a rapid onset of action is required, such as acute treatment of MI or before percutaneous coronary intervention (PCI). Similarly to immediate-release aspirin, Durlaza increases the risk of bleeding and gastric ulceration, and may cause fetal harm when given to a pregnant woman.

Durlaza is expected to be available in the fourth quarter of 2015. 

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