# A Long-Acting Bioabsorbable Naltrexone Subcutaneous Implant for Opioid Use Disorder

> **NIH NIH UG3** · DRUG DELIVERY COMPANY, LLC, THE · 2020 · $2,700,832

## Abstract

Project Summary/Abstract
The objectives for this proposal are (1) determining the optimal chemical preparation to inject into the implant for
delivery of Naltrexone (NTX) to minimize toxicity while maximizing efficacy, (2) determine the optimal
composition and porosity of the drug delivery implant to achieve the therapeutic serum levels of NTX as well as
(3) refinement of the surgical procedure and instrumentation to facilitate the safe and effective deployment of
the implant. To address these issues, the study team will execute the following specific aims: Aim 1: Validate
two formulations of NTX, liposomal encapsulation and PLGA encapsulation, for sustained release from the
implant with proof of in vitro stability and pharmacokinetics under GLP/GCP. Aim 2: Assess surgical procedure
and specialized instruments for replicable and safe implantation. Aim 3: Optimize the NTX drug formulation
and implant design in vivo. Aim 4: Complete a six to twelve-month study to verify the safety and efficacy of the
NTX implant needed for an Investigational New Drug/Investigational Device Exemption Application and
clinical trials.
As the opioid crisis lingers, the proposed study has direct application to the health concerns of the nation and to
the NIH as the study team seeks a fundamental solution and answer to enhance health, lengthen life, and reduce
illness and disability for those suffering from an Opioid Use Disorder (OUD).
The phases of the project will include: engineering, surgical technique refinement, pharmaceutical formulation,
bioanalytical evaluation - both: in vivo and in vitro, surgical implantation in 2 species, collection of the
pharmacokinetic bio-analytical data, toxicology/necropsy studies and analysis of the data. Specific tests and
comparisons will include NTX formulation (dissolution groups and 1-month in vivo (rodent)), balloon material
in vivo, (rodent), therapeutic (6 to 12 month in vivo rodent and canine), and control (6 to 12 month in vivo
rodent and canine) and opioid/fentanyl challenge in canines. Upon successful conclusion of the in vivo trials
with proven efficacy and safety, FDA approval and clinical trials will begin.
In the phase I study, we plan on testing 3 different doses of NI along with a placebo loaded implant in healthy
volunteers. The phase 2 clinical trial of the NI will be performed in subjects with OUD to determine the
efficacy, safety, tolerability and pharmacokinetics of the NI. We will assess two doses of NI and compare this to
the efficacy of a commercially available one month extended release naltrexone (XR-NTX) (Vivitrol, Alkermes)
given monthly for six months.

## Key facts

- **NIH application ID:** 9894780
- **Project number:** 5UG3DA048338-02
- **Recipient organization:** DRUG DELIVERY COMPANY, LLC, THE
- **Principal Investigator:** Jeffrey Benner
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,700,832
- **Award type:** 5
- **Project period:** 2019-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9894780

## Citation

> US National Institutes of Health, RePORTER application 9894780, A Long-Acting Bioabsorbable Naltrexone Subcutaneous Implant for Opioid Use Disorder (5UG3DA048338-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9894780. Licensed CC0.

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