Thursday, Adial Pharmaceuticals Inc (NASDAQ:ADIL) said it has completed a pharmacokinetics (PK) study of AD04 for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than ten drinks/drinking day).
This data will help the company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04.
Completing the study also satisfied an FDA requirement for the upcoming Phase 3 trials of AD04.
Also Read: EXCLUSIVE: Adial Pharmaceuticals Advances Regulatory Strategy For Companion Diagnostic Genetic Test For Its Lead Program For Alcohol Use Disorder
The single-center, relative bioavailability, open-label study enrolled 30 healthy adult volunteers in two cohorts.
Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg.
Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet.
The results of this study showed that, due to 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.
Its completion is in accordance with previous guidance provided by the FDA. This relatively short and low-cost study was key to the strategy to advance ongoing partnership discussions.
Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA.
The company plans to engage with the FDA during the fourth quarter of 2024 with the results of this pharmacokinetics study and obtain feedback that will assist with the AD04 Phase 3 study program.
Price Action: ADIL stock is down 0.01% at $0.99 during the premarket session at last check Thursday.
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