POZEN is currently seeking strategic partners to help maximize the opportunity for its portfolio assets.
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POZEN is creating a portfolio of integrated aspirin therapies - the PA product platform. The products in the PA portfolio are intended to significantly reduce GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and an indication will be sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
About the PA32540 Phase 3 Studies
The two Phase 3, double-blind, randomized, multicenter studies enrolled 1,049 subjects who were prescribed daily aspirin (325 mg) for greater than or equal to three months for secondary prevention of cardiovascular events. The primary endpoint was the cumulative observed incidence of gastric ulcers over six months. Secondary endpoints included cumulative incidence of gastric and duodenal ulcers, discontinuation due to pre-specified UGI adverse events and heartburn resolution. Subjects were randomly assigned to once-daily treatment with PA32540 or 325 mg of enteric-coated aspirin. Endoscopic assessments were performed at screening and at one, three and six months. Major adverse cardiac events (MACE) were reviewed and adjudicated by an independent, blinded endpoint committee composed of Cardiologists.
Each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone (Study 301: 3.8% vs. 8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively). In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations due to any adverse events (6.7% vs. 11.2%). Discontinuations due to pre-specified UGI events were lower in subjects taking PA32540 compared to subjects taking enteric coated aspirin (1.5% vs. 8.2% respectively, p<0.001).