Adial Pharmaceuticals Submits Briefing Package to Guide Upcoming FDA Meeting

Core Insights - Adial Pharmaceuticals has submitted a briefing package for the End of Phase 2 meeting with the FDA, now rescheduled for July 29, 2025, to discuss the clinical development plan for its lead drug AD04 [1][5] - The objective of the meeting is to align with the FDA on the Phase 3 clinical development program for AD04, which targets Alcohol Use Disorder (AUD) [3][4] - A successful outcome from the meeting is expected to enhance Adial's strategic partnership discussions, as regulatory clarity is crucial for potential collaborators [4][5] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with AD04 being a serotonin-3 receptor antagonist aimed at treating AUD in heavy drinkers [2][6] - The ONWARD™ pivotal Phase 3 clinical trial for AD04 has shown promising results in reducing drinking among heavy drinkers without significant safety concerns [6] Clinical Development - The briefing package for the EOP2M includes comprehensive safety data, efficacy studies, and statistical analysis conducted in collaboration with Cytel Inc. [3] - Key elements of the planned Phase 3 study design include population, endpoints, inclusion/exclusion criteria, and dose regime [3] Strategic Partnerships - Clarity and validation from the FDA are anticipated to strengthen Adial's position in discussions with potential partners, as regulatory momentum is viewed as a key de-risking milestone [4][5]