New Data Support Sustained Antiplatelet Effects With Durlaza

New Haven Pharmaceuticals announced new data that demonstrates Durlaza (aspirin) extended-release capsules provide sustained antiplatelet control for a full 24-hour period in high-risk patients. The data was released during a poster presentation at the American Heart Association’s Scientific Sessions event in Orlando, FL. is a low-dose, extended-release aspirin currently approved for the secondary prevention of stroke and acute cardiac events, including myocardial infarction. It works through extended-release microcapsule technology to prolong aspirin release. 

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The DURATION trial aimed to characterize the durability of platelet inhibition from Durlaza in this prothrombotic patient cohort. The study’s primary endpoint was change in platelet aggregation between 1 and 24 hours post-dosing. Researchers did not observe change in mean platelet aggregation at any time during the 23-hour time interval post-dose. Study findings indicate sustained stable platelet inhibition over the whole 24-hour dosing interval. 

A separate open-label, single-center study examined high-risk patients with type 2 diabetes with a history of cardiovascular disease (or multiple risk factors) that were treated daily with Durlaza for 14±4 days. Study results showed that the new extended-release formulation of aspirin provided safe and sustained antiplatelet effects for 24 hours in patients. 

Durlaza extended-release capsules will be available as a 162.5mg strength. It is expected to launch in early 2016.

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