Analyst Research

Report Title Price
Provider: Thomson Reuters Stock Report
$25.00
Provider: Pechala's Reports
$25.00
Provider: New Constructs, LLC
$25.00
Provider: MacroRisk Analytics/EconomicInvestor
$25.00

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

POZEN Inc Submits New Drug Application For PA32540/PA8140


Wednesday, 27 Mar 2013 07:30am EDT 

POZEN Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 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 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). 

Company Quote

8.73
0.26 +3.07%
16 Apr 2014