BioCorRx Inc. announced that it has received Independent Institutional Review Board (IRB) approval for the company's Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals Inc., the Company's controlled R&D subsidiary. The BICX104 clinical study is a Phase 1, open-label, single-center study in two parallel groups of 12 randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once a month intramuscular depot naltrexone injection. The study will be led by Dr. Joel M. Neutel M.D., Director of Research at the Orange County Research Center Orange County Research Center (OCRC), located in Tustin, CA.

BICX104 is being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company has an active Investigational New Drug (IND) status and the FDA has deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD).