New Haven Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Durlaza, the first and only once-daily 24-hour extended-release aspirin for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (MI).
The FDA approval of Durlaza was based on was approved based on the pharmacodynamic/pharmacokinetic results from the study NHP-ASP-01, which evaluated the ID50 of inhibition of serum Thromboxane A2 for both immediate release and extended-release aspirin. Based on the results of that study, Durlaza was approved as an extended-release aspirin formulation.
Durlaza is a nonsteroid anti-inflammatory drug indicated to reduce the risk of death and 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 and to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.
Durlaza utilizes extended-release, microcapsule technology to prolong aspirin release. In situations where a rapid onset of action is required, such as acute treatment of MI or before percutaneous coronary intervention, immediate-release aspirin should be used and not Durlaza. Like immediate-release aspirin, Durlaza increases the risk of bleeding and gastric ulceration, and may cause fetal harm when administered to a pregnant woman.