Adial Pharmaceuticals completed a pharmacokinetic study of AD04, a selective serotonin-3 receptor antagonist for Alcohol Use Disorder (AUD), and submitted the results to the FDA. The study, AD04-103, confirmed the drug’s bioavailability and dose proportionality in healthy volunteers, supporting the planned micro-dosing regimen for upcoming registration trials. This successful study paves the way for Adial to pursue FDA approval via the 505(b)(2) regulatory pathway.
This development is crucial because it validates AD04’s dosing strategy for pivotal trials, a critical step towards potential market entry. Confirming dose proportionality and lack of food effect simplifies administration for patients and reinforces the viability of the chosen micro-dosing approach. This also strengthens Adial’s regulatory strategy by fulfilling FDA bridging requirements for the 505(b)(2) pathway, which leverages existing data for ondansetron, potentially expediting the approval process.
The study, conducted in two cohorts with a total of 30 healthy volunteers, compared AD04’s pharmacokinetics to the marketed ondansetron. Results demonstrated dose proportionality across a three-fold AD04 dose range and showed no impact from food intake. This positive data allows Adial to proceed with its End-of-Phase 2 meeting with the FDA, planned for the first half of the year, to finalize the Phase 3 program design.
This milestone signifies a significant advancement in AD04’s development. A successful End-of-Phase 2 meeting will solidify the path to Phase 3 trials and potentially accelerate the timeline towards regulatory approval and commercialization. This also reinforces the potential of AD04 as a targeted therapy for AUD patients with specific 5-HT3 genotypes, offering a personalized approach to addiction treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
