Adial Pharmaceuticals completes EOP2 FDA meeting

Adial Pharmaceuticals (ADIL) announced the completion of a successful End of Phase 2 meeting, EOP2M, with the Food and Drug Administration, FDA. The FDA has provided input into the AD04 Phase 3 adaptive design clinical trial and the overall clinical program. Following the meeting, Adial is now prepared to advance AD04- its lead investigational drug and a serotonin-3 receptor antagonist- into its Phase 3 clinical development program for the treatment of Alcohol Use Disorder in individuals with heavy drinking and select genotypes and, most importantly, the AG+ genotype. The objective for the EOP2M was to align with the FDA on the design of the Phase 3 clinical development program for AD04. This included key elements of the planned adaptive study design elements, such as population, endpoints, inclusion/exclusion criteria, dose regime, and affirmation of the biomarker positive and biomarker negative groups.