R&D
About
BioCorRx Pharmaceuticals, Inc. is a biopharmaceutical company and a subsidiary of BioCorRx Inc. specializing in developing treatments for substance use disorder. However, the BioCorRx, Inc. program does not sell drugs or other compounds, any and all medications are selected and prescribed by the treating physician.
| 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