The aspirin combination drug that Pozen (NASDAQ:POZN) has developed to help prevent cardiovascular disease has been accepted by the Food and Drug Administration for review.
In accepting the new drug application for PA32540 and PA8140, two separate doses of the drug, the FDA said that it would fall under standard review, which means that the target date for an approval decision is January 24, 2014.
Chapel Hill-based Pozen is seeking approval for its PA drug, a drug developed to deliver the heart-protective properties of aspirin in a way that is easier on the stomach than aspirin alone. The tablet combines omeprazole around an aspirin core to coordinate delivery of the therapy. Omeprazole, a proton pump inhibitor that reduces gastrointestinal irritation, is released immediately. Aspirin is released later, giving the patient the benefits of aspirin in a way that reduces the risk of ulcers.
Aspirin, which has become part of the American Heart Association’s clinical guidelines for secondary prevention of cardiovascular events, has become the standard of care for reducing an individual’s risk of a second heart attack or stroke. Pozen is seeking drug approval for its PA drug for the secondary prevention of cardiovascular disease in patients at risk for gastric ulcers caused by aspirin.
If approved by the FDA, PA32540 and PA8140 would become Pozen’s third product approved for the U.S. market. The company has commercialized migraine headache drug Treximet with drug partner GlaxoSmithKline and osteo-arthritis drug Vimovo with drug partner AstraZeneca. The company is still seeking partners who could market the PA drug in the United States and abroad.
