pharmaceutical-technologyFebruary 09, 2017
Espero Pharmaceuticals has acquired the global rights to the US Food and Drug Administration (FDA)-approved Durlaza (aspirin) extended release capsules.
The commercially available prescription 24-hour extended-release capsule is indicated for the secondary treatment of stroke and acute cardiac events.
Durlaza was approved in September 2015 and has been designed to reduce the risk of death and myocardial infarction in patients with chronic coronary artery disease.
It also helps to reduce the risk of death and recurrent stroke in patients who had an ischemic stroke or transient ischemic attack (TIA).
Espero Pharmaceuticals CEO Quang Pham said: "According to the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) Task Force on Practice Guidelines, low-dose aspirin is a recommended treatment for patients with stable ischemic heart disease (SIHD), unless contraindicated, with the goal to improve survival.
"Durlaza was approved in September 2015 and has been designed to reduce the risk of death and myocardial infarction in patients with chronic coronary artery disease."
The company now has the two FDA-approved standard of care prescription medications Gonitro and Durlaza for treating SIHD.
Durlaza was previously marketed by New Haven Pharmaceuticals. It uses extended-release, microcapsule technology to prolong aspirin release and offers the 24-hour antiplatelet therapy through the extended release of its 162.5mg dose.
This results in prolonged absorption and sustained platelet exposure to aspirin.
The drug increases the risk of bleeding and gastric ulceration, and may cause foetal harm when administered to a pregnant woman.
Durlaza is indicated to reduce the risk of death and myocardial infarction (MI) in patients and also the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.
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