Pozen, Inc. Announces Positive Results for the PA8140-102 Bioavailability Study
Published: Nov 16, 2012
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the results from a Phase 1 study, PA8140-102, demonstrated that PA8140, POZEN’s proprietary combination of aspirin (81 mg) and omeprazole (40 mg), had comparable bioavailability relative to the reference listed product, enteric-coated (EC) aspirin (81 mg). In addition, based on predetermined criteria acceptable to the U.S. Food and Drug Administration (FDA), the study demonstrated that PA8140 is bioequivalent to EC aspirin (81 mg) using criteria for highly variable drugs. POZEN has now completed all of the clinical trials it intends to include in the PA32540/PA8140 New Drug Application (NDA) package.