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FAQ: BioCorRx's Clinical Study of BICX104 Naltrexone Implant
TL;DR
BioCorRx's BICX104 implant could offer a competitive edge by providing three months of sustained naltrexone delivery with a single minimally invasive procedure.
The Phase 1 study compares BICX104 with or without bupropion to Vivitrol, collecting pharmacokinetic and tolerability data over 84-day treatment and follow-up periods.
This long-acting implant could improve addiction treatment adherence and outcomes, potentially reducing relapse rates and supporting recovery for millions affected by substance use disorders.
BioCorRx is testing an implantable naltrexone pellet that releases medication for three months, offering a novel alternative to monthly injections for addiction treatment.
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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®.
BICX104 is an investigational long-acting subcutaneous naltrexone implant designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure.
The study aims to generate pharmacokinetic and tolerability data to support the continued development of BICX104 under the FDA's 505(b)(2) regulatory pathway, helping to inform subsequent development activities for this investigational long-acting formulation.
The study will enroll participants into four sequential cohorts and evaluate BICX104 administered alone and in combination with bupropion, with outcomes compared to those from participants receiving Vivitrol®, an approved extended-release naltrexone product.
Participants will complete an 84-day treatment period, followed by an 84-day follow-up period and a 28-day post-treatment observation phase, with the study now underway following completion of required institutional review requirements.
The study is being conducted by BioCorRx Pharmaceuticals, Inc., a majority-owned subsidiary of BioCorRx Inc., with research supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994.
Study assessments include pharmacokinetic sampling, monitoring of adverse events, laboratory evaluations, vital signs, and other tolerability measures.
BioCorRx Inc. is an addiction treatment solutions company offering the Beat Addiction Recovery program, which includes proprietary Cognitive Behavioral Therapy modules and peer support via mobile app, and operates through its subsidiary BioCorRx Pharmaceuticals Inc., which focuses on pharmaceutical commercialization and development.
For more information on BioCorRx and its subsidiary pipeline, visit www.BioCorRx.com, and for information on the UnCraveRx® Weight Loss Program, visit www.uncraverx.com. The clinical study is listed on ClinicalTrials.gov with Identifier: NCT07269873.
Curated from NewMediaWire
