POZEN Reports Top-Line Data from Long-Term Safety Study of PA32540

POZEN Inc.

announced today top-line results from study 303, a Phase 3 trial designed to track the long-term safety of PA32540 in patients who are at risk for developing aspirin-associated gastric ulcers. In this open label study, adverse events were consistent with what would be expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the PA components. The rate of discontinuation due to adverse events was low, and few patients developed major cardiovascular adverse events. “These data support the possibility that long-term treatment with PA32540 may provide patients with a safe and effective option for secondary prevention of cardiovascular events, including heart attacks and strokes,” said Tomás S. Bocanegra, M.D., FACP, Executive Vice President of Development of POZEN. “We are pleased that the results of this trial support the safety profile that we expected for PA32540. As soon as we obtain the results of the two ongoing pivotal Phase 3 trials in the first half of 2012, we will have all of the necessary components for the PA32540 NDA which is scheduled for submission to the FDA during the second half of 2012.”