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FDA approves extended-release aspirin for secondary prevention
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New Haven Pharmaceuticals announced FDA approval of its extended-release aspirin capsules for the secondary prevention of stroke and acute cardiac events in high-risk patients, according to a press release.
The 162.5-mg extended-release capsule (Durlaza, New Haven Pharmaceuticals) is formulated to gradually release the medication over 24 hours. It is indicated to reduce the risk for death and MI in patients with chronic CAD and to reduce the risk for death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack, according to the release.
Paul Gurbel
“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,” Paul Gurbel, MD, associate chief of research and director of the Sinai Center for Thrombosis Research and Sinai Hospital in Baltimore, said in the release. “[This] 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 CV risk prevention.”
The aspirin formulation will be available during the fourth quarter of 2015, according to the release.
Disclosure: Gurbel reports receiving grant support, consultant fees and/or honoraria from New Haven Pharmaceuticals.