POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced  top-line results from study 303, a phase III 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, MD, 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 III 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.”

PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a proton pump inhibitor (PPI), layered around pH-sensitive aspirin, is being investigated for the secondary prevention of cardiovascular disease in patients at risk for developing aspirin-associated gastric ulcers. This investigational product is part of POZEN's pipeline of integrated aspirin therapies, called the PA portfolio, all of which are designed to deliver the benefits of aspirin therapy with a reduced incidence of gastrointestinal toxicity.

Study 303 is a phase III, open-label study conducted at 39 medical centers around the United States. Subjects with known cardiovascular disease and already taking aspirin at a dose of 325 mg once daily were treated with PA32540 instead of their usual aspirin product once daily for as long as one year. As expected, most study participants had other comorbidities and were on many other concomitant medications. Of the 379 patients enrolled in this trial, 290 completed therapy for one year, 51 (13.4%) withdrew from the trial because of any adverse event, and one patient died. The cause of death, a non-haemorrhagic stroke, was judged by the investigator as being unrelated to PA32540.