FDA Approves Durlaza

FDA Approves Durlaza

New Haven Pharmaceuticals, Inc. a privately held specialty pharmaceuticals company, today announced that the U.S. 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 utilizes 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.

About Durlaza

Indication and Important Limitations of Use

Durlaza (aspirin) Extended Release Capsules 162.5 mg is indicated:

to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina
to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack
Limitation of use: Use immediate-release aspirin, not Durlaza in situations where a rapid onset of action of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

New Haven, CT, September 8th, 2015

Source: http://www.drugs.com

September 10, 2015 / Pharma News