Pozen Inc. (POZN)

[surf1944]

7:02AM POZEN announces new PA8140/PA32540 PDUFA date of April 25, 2014; results of a pharmacokinetic study to be submitted to and evaluated by FDA during 1Q2014 (POZN) 9.68 :

Co announced that following ongoing interactions with the FDA concerning its New Drug Application (NDA) for PA8140/PA32540 tablets, the co has decided to conduct a comparative Phase 1 pharmacokinetic study. The goal of the study is to determine the pharmacokinetic profile of the omeprazole component of PA8140 tablets and compare it to that of PA32540 tablets. Both PA dosage forms contain 40 mg of omeprazole in an immediate release form and are manufactured using nearly identical procedures.
The co anticipates that this study, which will enroll up to 30 subjects, will cost ~ $750,000. Final data are expected to be available in March 2014. POZEN and the FDA have agreed that the co will submit study information and data to the FDA as it becomes available during the conduct of the study and that FDA will review such information and data from the study when submitted. The FDA has informed POZEN that the co's user fee date of January 24, 2014 (PDUFA Date) is now April 25, 2014.