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Sep
11
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US FDA approves New Haven’s Durlaza ER capsules for secondary prevention of stroke & acute cardiac events
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New Haven Pharmaceuticals, Inc. a privately held specialty pharmaceuticals company, announced that the US Food and Drug Administration (FDA) has approved Durlaza (aspirin), the first and only 24-hour, extended release capsules, (162.5mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack).

“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” said 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.

“We are very pleased to have received FDA approval for Durlaza for secondary prevention for cardiovascular patients, and we now look forward to making it available by prescription in the fourth quarter of 2015,” said Patrick Fourteau, CEO of New Haven Pharmaceuticals.

“We believe Durlaza represents an important advancement by extending aspirin anti-platelet protection for high risk patients in the United States.”

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 (blood clotting).

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 utilises extended-release, microcapsule technology to prolong aspirin release. Durlaza offers the only 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. Durlaza, like immediate-release aspirin, increases the risk of bleeding and gastric ulceration, and may cause fetal harm when administered to a pregnant woman.
may cause severe urticaria, angioedema, or bronchospasm

Adverse reactions have been reported for products containing low dose aspirin including agitation, cerebral edema, coma, confusion, dizziness, headache, lethargy, seizures, hyperkalemia, metabolic acidosis, respiratory alkalosis, dyspepsia, hepatic enzyme elevation, hepatitis, Reye’s Syndrome, hearing loss, tinnitus, renal: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure.



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