Adial Pharmaceuticals announces topline results from AD04-103 PK study
The Fly

Adial Pharmaceuticals announces topline results from AD04-103 PK study

Adial Pharmaceuticals (ADIL) announced that it has completed a pharmacokinetics, PK, study of AD04, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of Alcohol Use Disorder in heavy drinking patients. This data will help the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study also satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04. The results of this study showed that, as a result of the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3-fold AD04 dose range; and AD04 can be taken in fed or fasted states

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