# Development of a 3-month implantable depot pellet of Naltrexone for the treatment of Opioid Use Disorder.

> **NIH NIH UG3** · BIOCORRX, INC. · 2020 · $2,831,838

## Abstract

BioCorRx is developing BICX102, a subcutaneous solid depot pellet of the opioid antagonist naltrexone (NTX).
NTX is a proven treatment for opioid use disorder (OUD). A single BICX102 implantation will provide continual
blockade of opioid receptors for up to 3 months. This can prevent patients from being affected adversely by
almost any opioid relapse event, while improving efficacy and adherence to behavioral programs that support
long term management and recovery. The BICX102 pellet can be removed if adverse drug reactions occur.
BICX102 is being developed via the 505(b)2 FDA pathway as NTX and the other ingredients have been
approved individually by the FDA; and BICX102 has been in clinical use in Russia as Prodetoxone® for >12
years. This UG3-UH3 proposal comprises the steps to achieve FDA approval. 2 million+ Americans have
OUDs, with ~42,000 opioid overdose deaths (2016). The opioid epidemic cost $504 billion in 2015. ~91% of
those in recovery experience relapse, and 80% do so within one month. Long-term abstinence is difficult to
achieve due to poor compliance to effective therapies like NTX tablets and monthly injections. Our innovative
solution is BICX102: a safe and effective 3-month subcutaneous depot pellet/implant containing NTX (1000
mg) that is less reliant on patient compliance. FDA guidance has indicated that they may rely on our proposed
studies and existing data on BICX102 and its ingredients for the basis for 505(b)2 approval. BioCorRx has a
team of experts in opioid treatment, regulation, CMC, nonclinical, clinical development and regulatory affairs to
complete this project using outstanding facilities that are routinely used in the studies proposed. Aim 1:
Chemistry Manufacturing and Controls (CMC): BICX102; Comprehensive Plan for Formulation
Development, Technology Transfer, Clinical Batch Manufacture, FDA Registration Batch Manufacture and
Stability Testing. Deliverable 1: Establish GMP facility to manufacture drug product (3-month Naltrexone/TCA
Implant) for research and development and commercialization. Aim 2: Pivotal GLP Safety, Pharmacokinetic
Study of BICX102, Revia, and Kenalog. Deliverable 2: Submission of IND application to the FDA for review.
UG3 Transition Milestone: Successful approval of the IND by the FDA to proceed to the clinical stage. Aim
3: Comparative Single and Multiple Dose Pharmacokinetics of 3-month BICX102 Naltrexone Depot.
Deliverable 3: Sustained release naltrexone serum levels above 1-2 ng/ml for up to 3 months. UH3
Milestone: Submission of 505(b)2 NDA application to FDA for marketing approval. Conclusion: Getting
BICX102 to the market quickly is a national priority which necessitates effective and timely interactions
between BioCorRx and the FDA. This milestone driven grant proposal is outstanding because it is following a
505(b)2 regulatory path that has been deemed acceptable by the FDA to achieve approval. We know from
extensive non-clinical and clinical studies that BICX102 will be effective...

## Key facts

- **NIH application ID:** 9851383
- **Project number:** 5UG3DA047925-02
- **Recipient organization:** BIOCORRX, INC.
- **Principal Investigator:** Andrew Peter Mallon
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,831,838
- **Award type:** 5
- **Project period:** 2019-02-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9851383

## Citation

> US National Institutes of Health, RePORTER application 9851383, Development of a 3-month implantable depot pellet of Naltrexone for the treatment of Opioid Use Disorder. (5UG3DA047925-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9851383. Licensed CC0.

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