Summary by Moomoo AI
On November 14, 2024, Adial Pharmaceuticals, Inc. announced the completion of a pharmacokinetics study for AD04, its investigational treatment for Alcohol Use Disorder (AUD). The study, which enrolled 30 healthy adult volunteers, aimed to evaluate the bioavailability and pharmacokinetic properties of AD04. Results indicated that AD04 has lower pharmacokinetic exposure compared to a standard ondansetron 4mg tablet, but exposure increases proportionally with the dose. The study also confirmed that AD04 can be taken with or without food. This data will be used to optimize the design for the upcoming Phase 3 clinical trial of AD04, which is also a requirement set by the FDA for the trial. The company plans to engage with the FDA in Q4 2024 to discuss the study results and receive feedback for the Phase 3 program. Adial Pharmaceuticals aims to advance AD04 towards regulatory approval and believes it has potential to treat other addictive disorders beyond AUD.
