Adial Pharmaceuticals has successfully completed a pharmacokinetic (PK) study of its drug candidate AD04 for Alcohol Use Disorder (AUD). This study, which met FDA requirements, provides crucial data for optimizing the design of upcoming Phase 3 clinical trials and potentially securing approval through a 505(b)(2) pathway. The results demonstrated that AD04 delivers lower ondansetron exposure than standard ondansetron tablets due to its lower dose, but exposure increases proportionally with dose and can be taken with or without food.
