Adial Pharmaceutical Announces Positive Findings From AD04-103 Pharmacokinetics Study

(RTTNews) - Adial Pharmaceuticals, Inc. (ADIL), Wednesday revealed positive results from its pharmacokinetics study of AD04 for the treatment of Alcohol Use Disorder in patients with a 5-HT3 genomic biomarker.

The AD04-103 study, involving 30 participants, aimed to evaluate the pharmacokinetics, bioavailability, and food effect of AD04 near-micro doses relative to marketed ondansetron in healthy volunteers.

The findings revealed that ondansetron pharmacokinetic exposure increased proportionally across a threefold AD04 dose range, between AD04 0.33 mg tablets and the marketed ondansetron 4 mg tablets.

The biopharmaceutical company also noted that AD04 can be taken with or without food.

Notably, Adial expects the findings to support the company's plans to pursue FDA approval of AD04 under the 505(b)(2) regulatory pathway.

The company has submitted the findings to the FDA, and intends to incorporate their feedback in the End-of-Phase 2 meeting, scheduled in the first half of this year.

Currently, Adial's stock is trading at $0.86, up 2.74 percent on the Nasdaq.