Adial Pharmaceuticals announced on January 29, 2025, the completion of its AD04-103 pharmacokinetics (PK) study and the submission of its results to the FDA. The study confirmed that AD04's formulation exhibited predictable bioavailability relative to the reference standard.
The results showed that near-micro doses of AD04 exhibited dose proportionality in pharmacokinetic exposure, and there was no food effect. The safety and tolerability profile was consistent with ondansetron’s extensive human use experience.
These study results support the near micro-dosing regimen planned for upcoming registration trials and conform with the FDA’s bridging requirements for a 505(b)(2) registration pathway. This completion enables the End-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program.
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