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.
Durlaza 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.
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.
For more information visit NewHavenPharma.com.