POZEN Submits New Drug Application for PA32540/PA8140
POZEN Inc. today announced the submission of a New Drug Application (NDA) to the FDA for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
“The NDA submission for PA32540/PA8140 represents an important milestone for PA,” said John R. Plachetka, Pharm.D., Chairman, President and Chief Executive Officer of POZEN. “Although this PA NDA is focused on patients who need the beneficial lifesaving cardiovascular properties of aspirin but are at risk for developing gastric ulcers, it is our hope that sometime in the future additional research will confirm the promise of aspirin as an important drug in the war against cancer, and perhaps other diseases. In discussions with potential partners, we believe we have seen the same commitment from them to transform the benefit/risk profile of aspirin that has driven our team at POZEN over the past several years. We look forward to completing a commercial deal in the upcoming months with a partner that shares our passion for this product, our values, and is capable of making PA reach its fullest potential in the marketplace.”
The NDA submission is based on data from a comprehensive clinical trials program that POZEN conducted. This program included two pivotal Phase 3 studies (PA32540 – 301/PA32540 – 302) for PA32540, conducted under special protocol assessment (SPA) agreed with the FDA, which met their primary and secondary endpoints, as well as extensive Phase 1 studies for both PA32540 and PA8140. In the 301 and 302 studies, significantly fewer subjects taking PA32540 experienced endoscopically confirmed gastric ulcers compared to subjects receiving enteric-coated (EC) aspirin alone (Study 301: 3.8% vs. 8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively).