Pozen has reported long-term safety results of open-label study 303 of PA32540 in patients at risk for developing aspirin-associated gastric ulcers.
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.
During the trial, 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 a year.
The trial results demonstrated that, of the 379 patients enrolled in the trial, 290 completed therapy for one year, 51 withdrew from the trial because of any adverse event and one patient died.
Pozen Development executive vice president Tomas Bocanegra said the study data supports 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.
"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," Bocanegra added.
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