BioCorRx Launches Phase 1 Trial for Long-Acting Naltrexone Implant

BioCorRx Inc. (OTCID: BICX), a developer of innovative substance abuse treatment programs, has announced a significant milestone in addiction medicine. The company's majority-owned subsidiary, BioCorRx Pharmaceuticals, Inc., has initiated a Phase 1 clinical study for BICX104, an investigational long-acting subcutaneous naltrexone implant. This study, titled "Safety and Pharmacokinetics Study of BICX104 With or Without Bupropion Compared to Vivitrol" (ClinicalTrials.gov Identifier: NCT07269873), is now underway following institutional review completion. The trial will compare BICX104 administered alone and in combination with bupropion against the FDA-approved extended-release naltrexone injection Vivitrol®, with the goal of generating pharmacokinetic and tolerability data to support continued development under the FDA's 505(b)(2) regulatory pathway.

The clinical trial represents a novel approach to addiction treatment, with BICX104 designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure. Participants will undergo an 84-day treatment period, followed by an 84-day follow-up period and a 28-day post-treatment observation phase. According to CEO Lourdes Felix, "The data generated will help inform subsequent development activities as we advance this investigational long-acting formulation." The study will enroll participants into four sequential cohorts, with assessments including pharmacokinetic sampling, adverse event monitoring, laboratory evaluations, and vital signs. This research is supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994, though the content remains the sole responsibility of the authors and doesn't necessarily represent official NIH views.

Beyond this specific clinical trial, BioCorRx operates multiple treatment programs addressing substance use disorders and related conditions. The company's Beat Addiction Recovery program combines proprietary Cognitive Behavioral Therapy (CBT) modules with peer support via mobile app and physician-prescribed medication. Additionally, BioCorRx offers the UnCraveRx® Weight Loss Program, which provides access to concierge wellness specialists including nutritionists and fitness experts. Through its pharmaceutical subsidiary, BioCorRx also commercializes LUCEMYRA® (lofexidine), an FDA-approved medication for mitigating opioid withdrawal symptoms in adults. The company's comprehensive approach addresses multiple public health challenges, including methamphetamine use disorder (MUD), which affects millions according to the National Survey on Drug Use and Health, and opioid use disorder (OUD), a chronic condition with serious consequences including disability and death. The global obesity epidemic, affecting an estimated 1 billion people worldwide according to the World Health Organization, further underscores the importance of innovative treatment solutions like those developed by BioCorRx.