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

> **NIH NIH UH3** · BIOCORRX, INC. · 2022 · $99,431

## Abstract

BioCorRx is developing a 3-month subcutaneous depot pellet formulation of naltrexone called BICX104 for the
prevention of relapse to opioid dependence, following opioid detoxification and the prevention of life-
threatening overdose. We are undertaking preclinical and clinical studies to support approval of BICX104. Data
management is currently centralized within BioCorRx without FAIR sharing processes. Data and documents
are focused upon the structuring of FDA submissions, internal reports, strategy and refinement of hypotheses
to enable project success. Commercial ventures are not incentivized to publish or FAIR share data and there is
a corporate culture of not sharing pharmaceutical development data. There is room for improvement if a
system can be developed by BioCorRx to enable standard formatting, FAIR sharing and collaboration whilst
protecting commercially sensitive information. All HEAL awardees would benefit greatly by having access to
different levels of such data and documents and we propose to improve or augment our processes and efforts
to enable FAIR sharing. We plan to develop and refine systems and strategies at BioCorRx that will format
data and documents; protect commercially sensitive information and enable proof of concept FAIR data
sharing. These activities will involve formatting, indexing, redacting, creating templates and making available
different BioCorRx data and documents. During this project we aim to develop practical improvements to
document and data as described and identified below. Advances modeled by this project could serve as an
exemplary pilot, and we will collaborate with RENCI/RTI and other HEAL ecosystem awardees during the
award period to discuss how this could be more broadly implemented in future. The majority of HEAL
awardees are commercial ventures that are working on highly regulated (FDA) projects encompassing
preclinical IND- and clinical NDA-enabling activities. The focus of the HEAL program on the opioid crisis
provides an opportunity to enable valuable data sharing that can be an opportunity to enhance awardee
success without compromising commercial positions. Findability: In order to serve HEAL awardees best,
BioCorRx will develop a common system of classification and ontology based upon 1) FDA Module/Section, 2)
pharmaceutical development stage, 3) indication and 4) product class. Accessibility: Convert BioCorRx data
and documents to enable access. Templates, partial redactions and SOPs will be developed to create a
system for creating documents and data for sharing. Interoperability: Conversion of data and documents for
sharing through shared databases using common formats that can ensure interoperability and import/export
with different programs and demonstrate utility. Reusable: Practical implementation and testing of the
BioCorRx FAI data accessibility.
BioCorRx will apply FAIR principles to data and documents generated. Subsequently, our proof of concept
project can help build a practic...

## Key facts

- **NIH application ID:** 10552495
- **Project number:** 3UH3DA047925-03S1
- **Recipient organization:** BIOCORRX, INC.
- **Principal Investigator:** Andrew Peter Mallon
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $99,431
- **Award type:** 3
- **Project period:** 2022-03-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10552495

## Citation

> US National Institutes of Health, RePORTER application 10552495, Development of a 3-month implantable depot pellet of Naltrexone for the treatment of Opioid Use Disorder. (3UH3DA047925-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10552495. Licensed CC0.

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