Adial Pharmaceuticals announced on November 14, 2024, the completion of its AD04-103 pharmacokinetics (PK) study for AD04, its investigational drug for Alcohol Use Disorder (AUD). The study yielded positive topline results, confirming predictable bioavailability relative to the reference standard.
The study demonstrated dose-proportional increases in pharmacokinetic exposure across a three-fold AD04 dose range, between 0.33 mg tablets and marketed ondansetron 4 mg tablets. Additionally, the results showed no food effect, meaning AD04 can be taken with or without food.
These findings support the near micro-dosing regimen planned for upcoming registration trials and conform with the FDA’s bridging requirements for a 505(b)(2) regulatory pathway. The safety and tolerability profile of AD04 was consistent with ondansetron’s extensive human use experience.
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