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POZEN Says FDA Does Not Agree That BioEquivalence Was Demonstrated


POZEN Inc. (NASDAQ: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it has received an Advice/Information Request letter from the U.S. Food & Drug Administration (FDA) which indicates that the FDA has made a preliminary review of the study results and POZEN's summary analyses of a Phase 1 study (115 Study) to assess the bioequivalence of PA32540 to enteric-coated (EC) aspirin 325 mg using acetylsalicylic acid (ASA) as the analyte. Based on its preliminary assessment, the FDA does not agree that bioequivalence of PA32540 to EC aspirin 325 mg was demonstrated based on the information available to the FDA at this time. The FDA indicated that the reference-scaled bioequivalence approach used in the 115 Study was justifiable for PA32540 in establishing bioequivalence with EC aspirin 325 mg with ASA as the analyte. In addition, FDA also advised POZEN that, as a general comment, for the development of a combination product with 81 mg aspirin, an in vivo bioequivalence study will be necessary unless a biowaiver can be further justified. POZEN has a planned follow-up call with the FDA in the next few weeks to determine next steps in satisfying the bioequivalence requirements and any impact on the New Drug Application (NDA) filing timeline.

Posted-In: News FDA


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