Adial Pharmaceuticals announce clinical study results from AD04-103 study

Adial Pharmaceuticals (ADIL) announced the completion of a pharmacokinetics study of AD04, and has made a regulatory submission of the results to the FDA. AD04 is the Company’s investigational drug candidate, a selective serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder, AUD, in patients with a 5-HT3 genomic biomarker. These study results support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and conform with the FDA’s bridging requirements for a 505(b)(2) registration pathway. The results of the study confirmed that ondansetron pharmacokinetic exposure increased proportionally across a three-fold AD04 dose range, between AD04 0.33 mg tablets and the marketed ondansetron 4 mg tablets. Additionally, the study demonstrated that AD04 can be taken with or without food.