PA32540 regulatory update

Pozen said that FDA told the company a Phase I trial of PA32540 does not satisfy an agency request to show bioequivalence to enteric-coated (EC) 325 mg aspirin prior to an NDA submission. PA32540 is a tablet containing 325 mg aspirin surrounded by an immediate-release coating of 40 mg omeprazole, a proton pump inhibitor (PPI). Pozen, which is pursuing an indication of secondary prevention of cardiovascular disease in patients at risk for gastric ulcers, said it plans to hold a follow-up call with FDA "in the next few weeks" to determine next steps.

In February, FDA requested the trial because EC products such as PA32540 and EC aspirin have highly variable pharmacokinetics, making bioequivalence difficult to demonstrate using traditional methods and standards. In March, Pozen said it planned to submit an NDA to FDA in 3Q12 after PA32540 met the primary endpoint in 2 Phase III trials (see BioCentury, March 26). ...