BioCorRx Inc. announced its submission to the US Food and Drug Administration (FDA) of an expanded access program application for BICX104 (implantable naltrexone pellet) for the treatment of opioid use disorder (OUD) patients that meet program eligibility criteria. Expanded access (also known as ?compassionate use?) is an FDA program that allows drug companies to provide access to an investigational medical product before full FDA approval to patients with a serious or immediately life-threatening disease or condition where standard treatment options have been exhausted or are not suitable. Data published on the FDA website indicates a 98.4% approval rate (62 out of 63) for expanded access applications submitted to the Center for Drug Evaluation and Research (CDER) for treatment protocols between 2018 and 2022.

BICX104, which is being developed by BioCorRx Pharmaceuticals Inc., the Company?s controlled clinical-stage pharmaceutical subsidiary, is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of OUD being developed with the goal of improving patient compliance to naltrexone therapy compared to other marketed treatments. The BICX104 clinical study was a Phase I, open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the PK and safety of BICX104 implantable subcutaneous naltrexone pellets and the marketed once-a-month intramuscular depot naltrexone injection, Vivitrol. Information about the study can also be found at www.clinicaltrials.gov under NCT number 04828694.

BICX104 is being developed through a cooperative agreement with the NIDA, part of NIH, under award number UH3DA047925, funded by the Helping to End Addiction Long-term Initiative or NIH HEAL Initiative. This award is subject to the Cooperative Agreement Terms and Conditions of Award as set forth in RFA DA-19-002 entitled, Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional). The NIH Helping to End Addiction Long-term® Initiative or NIH HEAL Initiative®, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis.

Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management.