BioCorRx Subsidiary Initiates Clinical Study for Long-Acting Naltrexone Implant

BioCorRx Inc. announced that its majority-owned subsidiary, BioCorRx Pharmaceuticals, Inc., has initiated a Phase 1 clinical study evaluating BICX104, an investigational long-acting subcutaneous naltrexone implant, administered with or without bupropion, compared to the FDA-approved extended-release naltrexone injection Vivitrol®. The study, titled Safety and Pharmacokinetics Study of BICX104 With or Without Bupropion Compared to Vivitrol and registered under ClinicalTrials.gov Identifier: NCT07269873, is now underway following completion of required institutional review requirements. This development matters because it represents a potential advancement in sustained-release treatment options for substance use disorders, which affect millions globally.

The trial is designed to generate pharmacokinetic and tolerability data to support the continued development of BICX104 under the FDA’s 505(b)(2) regulatory pathway. Lourdes Felix, CEO of BioCorRx Inc., stated that the data generated will help inform subsequent development activities as the company advances this investigational long-acting formulation. The clinical trial will enroll participants into four sequential cohorts and evaluate BICX104 administered alone and in combination with bupropion. BICX104 is designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure.

Participants will complete an 84-day treatment period, followed by an 84-day follow-up period and a 28-day post-treatment observation phase. Study assessments include pharmacokinetic sampling, monitoring of adverse events, laboratory evaluations, vital signs, and other tolerability measures. Outcomes from the investigational arms will be compared to those from participants receiving Vivitrol®, an approved extended-release naltrexone product. The importance of this study lies in its potential to offer a longer-acting alternative to existing treatments, which could improve adherence and outcomes for patients with substance use disorders.

Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. According to the 2022 National Survey on Drug Use and Health, more than 16.6 million people used methamphetamine at least once during their lifetime, highlighting the significant need for effective treatments. The World Health Organization reported in 2024 that one in eight people live with obesity and stressed the importance and need to curb the obesity epidemic with new interventions, which could be relevant given the study's inclusion of bupropion, a medication sometimes used for weight management.

BioCorRx also operates through its subsidiary, BioCorRx Pharmaceuticals Inc., which focuses on pharmaceutical commercialization and development, including LUCEMYRA® (lofexidine), an FDA-approved medication indicated to mitigate opioid withdrawal symptoms in adults. For more information on BICX and its subsidiary pipeline, please visit https://www.BioCorRx.com. The UnCraveRx® Weight Loss Program is a medication-assisted weight loss program that includes access to concierge on-demand wellness specialists; for more information on UnCraveRx®, please visit https://www.uncraverx.com. This clinical study initiation underscores BioCorRx's broader strategy to address substance abuse and related disorders through innovative pharmaceutical and behavioral approaches.