POZEN has submitted a New Drug Application to the FDA for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combination of immediate-release omeprazole 40mg, a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core.
The NDA submission is based on data from a comprehensive clinical trials program conducted by POZEN. This program included two pivotal Phase 3 studies (PA32540–301/PA32540–302) for PA32540, which met their primary endpoints, as well as extensive Phase 1 studies for both PA32540 and PA8140. In the 301 and 302 studies, significantly fewer patients taking PA32540 experienced endoscopically confirmed gastric ulcers compared to patients 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).
POZEN is seeking an approval for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
For more information call (919) 913-1030 or visit www.pozen.com.