Adial Pharma Advances AD04 For Alcohol Use Disorder With FDA Submission

Adial Pharmaceuticals, Inc. announced the completion of its pharmacokinetics (PK) study for AD04 and submitted results to the FDA. The company's promising drug candidate, AD04, functions as a selective serotonin-3 receptor (5-HT3) antagonist to treat Alcohol Use Disorder (AUD) in patients exhibiting a 5-HT3 genomic biomarker. These observations from the study validate the AD04 near micro-dosing approach for future clinical trials while fulfilling FDA conditions for 505(b)(2) drug approval regulations. 

AD04-103 served to assess and establish the pharmacokinetic values along with dietary effects on AD04 minimal dose quantities compared to the available ondansetron version among healthy subjects. The investigation carried out its measurements across two distinct phases among thirty healthy volunteers separated between two research groups. 

Cary Claiborne, President and Chief Executive Officer of Adial, said in a statement, “Successful completion of this bridging study supports our plans to pursue FDA approval of AD04 under the 505(b)(2) regulatory pathway. We have engaged with the FDA on the results of this PK bridging study and will incorporate their feedback as we prepare for our End-of-Phase 2 meeting, which is targeted to take place in the first half of this year. We are excited to achieve this important milestone on the path toward regulatory approval.” 

The first Cohort 1 (n=6), was a randomized, open-label crossover study that explored ondansetron pharmacokinetic variability between AD04 doses of 0.33 mg and 0.99 mg. The second Cohort 2 (n=24), was an open-label randomized crossover study that assessed the AD04 0.33 mg tablet's bioavailability relative to marketed ondansetron 4 mg tablets alongside testing for ondansetron dose proportionality between these doses and the effects of food on the drug's bioavailability when administered as AD04 0.33 mg tablets. 

The research data showed that administration of AD04 0.33 mg tablets at three-fold levels from AD04 0.33 mg to ondansetron 4 mg led to equivalent pharmacokinetic exposure to ondansetron. Research findings showed that AD04 maintains bioavailability regardless of whether patients take it after eating or on an empty stomach.