POZEN Inc. (NASDAQ: POZN)
a pharmaceutical company committed to transforming medicine that transforms lives, today announced the results of the Company’s Type A meeting with the U.S. Food and Drug Administration (FDA) regarding issues related to POZEN’s planned New Drug Application (NDA) for PA32540 and PA8140 (high and lower dose versions of 325 mg aspirin delayed-release and 40 mg omeprazole immediate-release, and 81 mg aspirin delayed-release and 40 mg omeprazole immediate-release, respectively) for the secondary prevention of cardio - and cerebrovascular events and to reduce the risk of gastric ulcers in patients at risk of aspirin induced gastric ulcers.
The FDA confirmed that, although the Agency believes bioequivalence of PA32540 to enteric-coated Ecotrin
325 mg, the Reference Listed Drug (RLD), was not strictly established in Study 115 according to the predetermined criteria, the results from Study 115, together with additional information that will be submitted in the NDA, constitutes sufficient data to support the establishment of a bridge to Ecotrin
325 mg under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The FDA will make a final determination during the NDA review. Based on our discussions with the FDA, POZEN does not plan to conduct any further bioequivalence studies with PA32540.
The FDA also indicated that a similar strategy to bridge to the RLD under Section 505(b)(2), inclusive of a new, single pharmacokinetic study, could be utilized for a low dose version of PA32540 (currently, PA8140). POZEN plans to conduct this study with the low dose version against the RLD, EC-Ecotrin
81 mg, and submit these results and other supporting data in the NDA. POZEN also confirmed with the FDA that no additional clinical data would be submitted for a lower dose version and, in particular, that no Phase 3 program will be conducted.
In addition, the FDA has confirmed its preference to have both PA32540 and a lower dose version available in the market so that physicians can have both a low and high dose option available, and agreed that, if both dosage strengths were included in the NDA and subsequently approved, the indications for both will be consistent with the full range of indications described in the current aspirin monograph.