FX.co ★ Adial Pharmaceutical Announces Positive Findings From AD04-103 Pharmacokinetics Study

Adial Pharmaceuticals, Inc. (ADIL) announced encouraging outcomes from its pharmacokinetics study of AD04, designed for treating Alcohol Use Disorder in patients with a 5-HT3 genomic biomarker. The AD04-103 study assessed the pharmacokinetics, bioavailability, and food effect of AD04, involving 30 participants, in comparison to established ondansetron in healthy individuals. Results indicated that ondansetron's pharmacokinetic exposure increased consistently across a threefold AD04 dosage range, from AD04 0.33 mg tablets to the marketed ondansetron 4 mg tablets. Adial confirmed that AD04 is effective whether taken with or without meals. Importantly, these results are expected to bolster Adial’s efforts to obtain FDA approval for AD04 through the 505(b)(2) regulatory pathway. The findings have been submitted to the FDA, and Adial plans to incorporate the agency's feedback during their End-of-Phase 2 meeting, anticipated in the first half of this year. Presently, Adial's shares are priced at $0.86, reflecting a 2.74 percent increase on the Nasdaq.