Technology | Antiplatelet and Anticoagulation Therapies | September 11, 2015

New Haven Pharmaceuticals Receives FDA Approval for Durlaza Extended-Release Capsules

Once-daily aspirin designed for secondary, continuous prevention of stroke and acute cardiac events

New Haven Pharmaceuticals, FDA approval, Durlaza, antiplatelet, once-daily, extended-release

September 11, 2015 — New Haven Pharmaceuticals Inc. announced U.S. Food and Drug Administration (FDA) approval of Durlaza (aspirin) 24-hour extended-release capsules for the secondary prevention of stroke and acute cardiac events, including myocardial infarction.

"Durlaza is an aspirin formulation for secondary prevention in high-risk CVD [cardiovascular disease] 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," said Paul Gurbel, M.D., associate chief for research and director of the Sinai Center for Thrombosis Research, Sinai Hospital, Baltimore; professor of medicine, Johns Hopkins University; and adjunct professor of medicine, Duke University.

Low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular disease. This is primarily due to aspirin's ability to inhibit platelet aggregation.

While the body is making platelets 24 hours a day, current immediate-release traditional aspirin only stays in the blood for about a mean duration of four to six hours, with peak plasma concentrations peaking after just 30 minutes. Durlaza utilizes extended-release, microcapsule technology to prolong aspirin release. The capsules offer once-daily, 24- hour antiplatelet therapy through the extended release of its 162.5mg dose, resulting in prolonged absorption and sustained platelet exposure to aspirin. 

For more information: www.newhavenpharma.com

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