POZEN announced that the results from a Phase 1 study, PA8140-102, demonstrated that PA8140, POZEN’s proprietary combination of aspirin and omeprazole, had comparable bioavailability relative to the reference listed product, enteric-coated aspirin. In addition, based on predetermined criteria acceptable to the U.S. Food and Drug Administration, the study demonstrated that PA8140 is bioequivalent to EC aspirin 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 package. 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.
- Pharmaceuticals & Drug Trials