POZEN is creating a safer form of aspirin franchise of product candidates – the PA product platform. The PA family of product candidates is intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.
The first candidate is PA32540. It is a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a PPI, layered around pH-sensitive enteric-coated aspirin (325 mg). This novel, patented product candidate is in Phase 3, and is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. POZEN has completed enrollment of patients in two pivotal Phase 3 trials. A long-term, open-label safety trial for secondary cardiovascular disease (CVD) prevention was completed in 2011.
Development Program – PA/CA
The product candidates combine aspirin with a PPI for cardiovascular protection along with the potential reduction in the risk of colorectal cancer and adenomas. Adenomas are precursors of most colorectal cancers and prevention of adenomas will most likely also prevent colorectal cancer, as reported in the New England Journal of Medicine in March 2003. The PA/CA product candidates are intended to provide fewer gastrointestinal side effects and complications compared to an NSAID or enteric coated aspirin taken alone. POZEN has completed proof-of-concept studies with its PA product candidate with positive results. POZEN is planning to start Phase 3 pivotal studies in mid-2009.
PA Proof of Concept Study Results
PA 32520 vs. 325mg EC Aspirin
PA 32520 vs. 81mg EC Aspirin
PA 32540 vs. 325mg EC Aspirin
