AD/04 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.  
• AD/04 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 addiction.  When paired with our genetic test to focus on the most appropriate patients, AD/04 was found to significantly reduce days of drinking in patients with certain genotypes.

 

Having successfully completed a large Phase III trial, ADial is now in the process of clarifying the structure, size, and requirements with the FDA for a pivotal Phase III trial.