Adial Pharmaceuticals Announces Positive Topline Results from AD04 Pharmacokinetics Study for Alcohol Use Disorder

ADIAL PHARMACEUTICALS, INC.

Study enrolled 30 healthy volunteers in two cohorts: Cohort 1 (n=6) evaluated PK variability; Cohort 2 (n=24) assessed relative bioavailability, dose proportionality, and food effect.
Results showed AD04 0.33mg delivered lower ondansetron PK exposure than marketed 4mg tablet; exposure increased proportionally across 3-fold dose range; no food effect observed.
Completion of the study satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04 and supports 505(b)(2) regulatory pathway.
Company plans to engage with FDA in Q4 2024 to discuss study design for Phase 3, aiming to enhance likelihood of success and advance partnership discussions.
Continued excellent safety and tolerability findings consistent with extensive human use experience with ondansetron.

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