Adial Pharmaceuticals Receives FDA Feedback on AD04 Phase 3 Trial Design

Adial Pharmaceuticals, Inc. announced the receipt of final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) regarding the AD04 Phase 3 adaptive clinical trial design. The FDA provided positive feedback on the trial design, including support for the adaptive trial design, primary efficacy endpoints, and safety monitoring framework. The FDA also recognized Alcohol Use Disorder (AUD) as an unmet need and supported the company's plan to account for homozygous populations. This feedback marks a key milestone in advancing AD04 toward registration. The company is now positioned to advance a streamlined and scientifically rigorous program designed to maximize the probability of success.