AD04 is a proprietary dosage of the generic version of ondansentron. ADial’s work with this lead compound, and our completion of a large Phase II trial, are notable and offer the following significant differentiators from both currently approved treatments as well as those under investigation by other companies within the research community:
- Review of data from our large Phase II trial indicates a clinically and statistically significant result in reducing heavy drinking.
- AD04 treatment does not require abstinence prior to, during, and after treatment.
- Our proprietary dosage has a demonstrated side effect profile similar to placebo, with a large volume of reliable safety data.
Additionally, ADial has created a proprietary genetic diagnostic test based upon our significant research within the alcohol addiction space. This test denotes focused differences in allelic genotypes as a means for channeling patients to the most effective treatment for their Alcohol Use Disorder. When paired with our genetic test to focus on the most appropriate patients, AD04 was found to significantly reduce days of drinking in patients with certain genotypes.
Having successfully completed a large Phase II trial, ADial is now in the process of clarifying the structure, size, and requirements with the FDA for a pivotal Phase III trial.