R&D
About
BioCorRx Pharmaceuticals, Inc. is a commercial and clinical stage biotechnology company and a subsidiary of BioCorRx Inc. specializing in developing treatments for substance use disorder.
| Candidate & Indication | Development Stage | ||||
|---|---|---|---|---|---|
| Preclinical | Phase 1 | Phase 2 | Phase 3 | FDA Approval | |
| Long-acting solid depot naltrexone Opioid and Alcohol Addiction |
Preclinical Phase complete
|
Phase 1 Phase in progress
|
Phase 2 Phase not started
|
Phase 3 Phase not started
|
FDA Approval Phase not started
|
Overview
Lead candidate, BICX104, is a subcutaneous implantable naltrexone pellet being developed to address both opioid and alcohol use disorders (OUD & AUD). Naltrexone is an opioid antagonist already FDA approved in other delivery forms for these indications. BICX104 is designed to last about 3 months after one dose.
- Completely biodegrades eliminating the need to remove after implantation
- Nearly pure naltrexone pellet devoid of polymers
- Simple in-office procedure in approximately 15 minutes using local anesthetic.
- Removeable in the event narcotic pain relief is needed due to injury or elective decision
- Addresses patient non-compliance with adherence to daily or monthly administration of other naltrexone products
- 505(B)(2) pathway deemed acceptable by FDA for both AUD and OUD in one application and no efficacy studies required
- Received funding from NIH/NIDA (National Institutes of Health and National Institute on Drug Abuse)
- Received FDA Clearance of Investigational New Drug (IND) application for BICX104 in 2021
- Phase 1 human trial completed March 22, 2023
- Interim data demonstrate that BICX104 is well-tolerated and achieves desired 84-day therapeutic naltrexone levels
- Seeking Fast Track Designation and Expanded Access