Pozen: FDA starts review of cardiovascular drug

Pozen says FDA is reviewing cardiovascular disease drug intended as an alternate to aspirin

Associated Press

CHAPEL HILL, N.C. (AP) -- Drug developer Pozen Inc. said Wednesday that the Food and Drug Administration is now reviewing an experimental cardiovascular drug it developed.

Pozen said the FDA will conduct a standard review and should make a decision on its application by Jan. 24. Regulators will evaluate two doses of the drug, which combines aspirin with omeprazole, the active ingredient in heartburn drugs like Prilosec.

The drug is intended as an alternative to aspirin as a secondary treatment for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers. In Pozen's drugs, the omeprazole is released as soon as the tablet is taken and the aspirin is released over time.

The higher-dose version of the drug is designated PA32540 because it contains 325 milligrams of aspirin and 40 grams of omeprazole. The other version is called PA8140, and it contains 81 milligrams and aspirin and 40 milligrams of omeprazole. The FDA encouraged Pozen to study the lower-dose version and said in 2012 that it might only approve the larger-dose version for limited groups of patients.

Shares of Pozen slipped 5 cents to $5.17 in morning trading.

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