FDA-approved, once-daily 24-hour aspirin now available for prevention of stroke and acute cardiac events

Jan 7 2016

New Haven Pharmaceuticals, Inc. today announced the availability by prescription of DURLAZA™, the first and only 24-hour, extended-release aspirin capsules (162.5mg) approved by the U.S. Food and Drug Administration (FDA) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients. DURLAZA is now commercially available for physicians and their patients.

"We are very pleased to announce the national availability of DURLAZA as a new, novel alternative option for high-risk cardiovascular patients who would benefit from increased all-day protection from clotting risks," said Patrick Fourteau, CEO of New Haven Pharmaceuticals. "We are confident of the positive effects that DURLAZA has on stabilizing and maintaining platelet inhibition for a full 24-hours – no other single, low-dose aspirin can offer this level of coverage to these patients. We believe that DURLAZA offers a significant benefit by reducing the risk of secondary strokes and heart attacks."

DURLAZA received FDA approval in September 2015. In an open-label, single-center study, high-risk patients with Type II Diabetes (T2DM) with a history of Cardiovascular Disease (or multiple CV risk factors) were treated daily with DURLAZA for 14 days +/- 4 days. The assessment concluded that the new, extended-release orally administered aspirin formulation provided sustained antiplatelet effects over 24 hours in patients with a favorable safety profile.

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). DURLAZA's 24-hour extended delivery helps maximize the benefit of aspirin by providing consistent platelet inhibition around the clock and the potential for improved patient compliance and adherence to aspirin therapy.

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.