PA-325/40 (EC-ASA 325 mg + IR omeprazole 40 mg)
enteric-coated aspirin (EC-ASA) 325 mg
Pozen Inc. announced the submission of a new drug application to the U.S. Food and Drug Administration for the marketing approval of two potential cardiovascular drugs.
The move is a major step toward commercializing the drugs and means that the company thinks it has proven that the drugs are safe and effective.
Pozen’s PA32540 and PA8140 are both intended as alternatives to plain aspirin for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers.
Pozen’s drugs contain aspirin and the omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.
Pozen is seeking approval for use in patients at risk of aspirin-induced ulcers.
Pozen CEO John Plachetka called the move “an important milestone for the drug” and said the company looks forward to completing a commercial deal with a partner “in the upcoming months.”
Pozen’s PA-325/40 is a combination pill containing enteric-coated aspirin 325 mg surrounded by a pH-sensitive film surrounded by an immediate-release omeprazole 40 mg.