Pozen says drug candidate shows bioequivalence

Drug developer Pozen Inc. said Monday that a cardiovascular disease drug candidate demonstrated bioequivalence to enteric-coated aspirin, possibly paving the way for regulatory approval.

Bioequivalence means the active ingredient of a drug is absorbed and metabolized in the body in about the same amount, over about the same time, as the active ingredient in a comparable drug.

Pozen also said it submitted a special protocol assessment with the Food and Drug Administration with regards to late-stage trials for PA32540. An SPA agreement generally reduces the risks involved in developing a drug because the drug maker and the FDA agree ahead of time on how the trial will be conducted, and what will be considered proof that the drug works.

The company added PA32540 is designed to have the cardiovascular benefits of aspirin, but with a lower rate of ulcers than enteric-coated aspirin. Aspirin is often used for the prevention of heart attacks and strokes.

PA32540 contains aspirin and the heartburn drug omeprazole, which is sold as the over-the-counter medication Prilosec OTC by Procter & Gamble Pharmaceuticals.

Shares of Pozen fell 18 cents to $13.50 in midday trading.