Adial Pharmaceuticals Receives Positive Response from FDA Meeting Regarding Proposed In Vitro Bridging Strategy for AD04

Core Insights - Adial Pharmaceuticals received positive feedback from the FDA regarding its proposed in vitro bridging strategy for the AD04 formulation, which is essential for the 505(b)(2) regulatory registration pathway [1][3][4] - The FDA's agreement allows Adial to proceed with the manufacturing of clinical supplies for the upcoming Phase 3 clinical program scheduled for 2025 [1][4] Regulatory Approval Process - The FDA's feedback followed Adial's submission on November 19, 2024, which sought guidance on the alignment of its AD04 formulation strategy and bridging approach [2] - The proposed bridging strategy involves using results from the AD04-103 study, a relative bioavailability food-effect study, along with in vitro dissolution data to demonstrate equivalence between the reference product and the planned commercial formulation of AD04 [3] Clinical Development - With regulatory confirmation, Adial is advancing its development plan to bring AD04 to market as a potential breakthrough therapy for addiction [4][5] - AD04 is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) and has shown promising results in reducing heavy drinking in patients during the ONWARD™ pivotal Phase 3 clinical trial [5]