New Haven Pharmaceuticals Presents Positive Data That Shows DURLAZA™ is Well Tolerated and Delivers Sustained 24-hour Antiplatelet Control

NEW HAVEN, Conn., New Haven Pharmaceuticals, Inc. today announced positive study data that shows that DURLAZA™ is well tolerated, with a favorable safety profile comparable to immediate release low dose aspirin and delivers sustained antiplatelet control for a full 24-hour period in high-risk cardiovascular and diabetes patients. These data were highlighted during poster presentations at the Annual American College of Preventive Medicine (ACPM) meeting in Arlington, VA.

The studies, titled, "A New Extended-Release Acetylsalicylic Acid (ASA) Formulation is Well Tolerated: Analysis of 3 Double-Blind Studies" and "Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic acid, DURLAZA, in Patients with Diabetes," were presented by Jeff Patrick, Pharm.D., Chief Scientific Officer at New Haven Pharmaceuticals.

Patrick Fourteau, CEO of New Haven Pharmaceuticals, said, "These positive data show that DURLAZA is well tolerated, and its antiplatelet activity for a full 24-hours provides a significant benefit to patients who have diabetes and cardiovascular disease, by preventing blood clotting, which may cause a secondary heart attack or stroke."

DURLAZA is the first prescription, low dose, extended-release aspirin, (162.5mg), for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack), in high risk cardiovascular and diabetes patients.

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.

Interested patients should consult with a physician regarding which prescription options are most suitable for their specific needs.

Source: New Haven Pharmaceuticals, Inc.