Summary by Moomoo AI
Adial Pharmaceuticals has completed a crucial pharmacokinetics (PK) study of AD04, its lead investigational drug for Alcohol Use Disorder (AUD) treatment. The study enrolled 30 healthy volunteers across two cohorts, evaluating the bioavailability and dosing characteristics of AD04 compared to standard ondansetron. The study satisfied FDA requirements for upcoming Phase 3 trials.Results showed that AD04 0.33mg delivered lower ondansetron exposure than the 4mg reference tablet, demonstrated dose-proportional pharmacokinetic exposure across a 3-fold range, and confirmed that AD04 can be taken with or without food. This data will help optimize the Phase 3 trial design and support the 505(b)(2) regulatory pathway.The company plans to engage with the FDA in Q4 2024 to discuss the study results and receive feedback for the Phase 3 program. The completion of this study advances ongoing partnership discussions and enhances the likelihood of success in upcoming Phase 3 trials.
