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, a PPI, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease. POZEN has started enrolling patients in two pivotal Phase 3 trials and a long-term, open-label safety trial for secondary cardiovascular disease (CVD) prevention in October 2009.

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