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.
"Based on earlier studies with PA formulations and discussions with the FDA, we made adjustments in the trial design, which improved our ability to both capture and measure blood levels of aspirin, as compared to the PA32540-115 trial," said Dr. John Fort, Chief Medical Officer. "We believe that these results will satisfy the requirements set forth by the FDA for establishing a therapeutic bridge to EC aspirin (81 mg) for this lower strength of PA tablets."
Additionally, POZEN announced that it has successfully manufactured the PA8140 tablet batches required for the primary NDA stability program and that these batches met all predetermined specifications. Based upon the successful completion of these activities, POZEN is now targeting submission of the NDA no later than the end of April 2013.
"If approved, the availability of both 81 mg and 325 mg doses of PA will allow us to provide physicians an option for virtually all of their secondary prevention cardiovascular patients who are at risk for gastric ulcers, dramatically improving the commercial opportunity for PA," said Liz Cermak, Chief Commercial Officer and Executive Vice President.