# Evaluation of safety and pharmacokinetics of naltrexone implant

> **NIH NIH UH3** · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · 2022 · $4,087,023

## Abstract

New medication treatment approaches are needed to help address the severe epidemic of opioid use
disorder (OUD) and opioid overdose deaths in the US. Currently available medications, methadone,
buprenorphine, and extended release injection naltrexone (XR-NTX; trade name: Vivitrol), are highly
efficacious, but their effectiveness in practice is limited by poor adherence, with many patients stopping
treatment prematurely and relapsing. The goal of this proposal is to develop an innovative long acting
subcutaneous implanted formulation of naltrexone, the O’Neil Long-Acting Naltrexone Implant (OLANI),
towards FDA approval. Expected to produce naltrexone blood levels sufficient to block the effects of opioids
for 6 months after implant, OLANI circumvents the need for adherence to monthly injections with XR-NTX, and
could represent an important new addition to the medical armamentarium for treatment of OUD.
 The OLANI has been in development by an Australian company Go Medical for 20 years with several
prototypes evaluated in controlled clinical trials and used clinically in Australia. The current formulation has
higher drug loading and a better release profile and is manufactured in a GMP facility. It has been used
clinically in over 800 patients, giving confidence that the product can be successfully developed in the US. Go
Medical and the current team of investigators met with the FDA to chart a development path towards a New
Drug Application (NDA) via the 505 b(2) pathway with Vivitrol as a comparator product. An application for an
IND (# 134996) is under review by the FDA. This proposal seeks NIDA’s support under the UG3/UH3
mechanism to conduct the studies recommended by the FDA for the 505 b(2) pathway to approval.
 Under the UG3 Phase, Study 1 will evaluate local tissue toxicity of OLANI in a minipig model, and
Study 2 will generate pilot pharmacokinetic (PK) data of OLANI in healthy subjects in order to determine power
and finalize sample size for a subsequent bioequivalence (BE) study and to support feasibility and tolerability.
If there are no safety concerns and naltrexone blood levels are adequate in the UG3 phase, then in the UH3
phase (Study 3) will be finalized in consultation with NIDA and FDA. Study 3 will compare 6-month PK of
OLANI versus XR-NTX as the reference drug to establish bioequivalence (BE) in terms of naltrexone blood
levels, safety and comparative effectiveness in patients with OUD. Patients will be randomized to receive
either a single subcutaneous implantation of 3.6g dose of OLANI or repeat doses of Vivitrol 380 mg IM q4
weeks for 24 weeks. Participants randomized to OLANI will be offered an additional implant at month 6. We
hypothesize that OLANI will have a systemic exposure (Cmax,Cmin,AUC0-180) and MEC of naltrexone blood
levels comparable to XR-NTX. If OLANI is shown to provide a safe, feasible and effective method of delivery
of naltrexone at therapeutic levels for at least 6 months, it would represent a major adv...

## Key facts

- **NIH application ID:** 10366089
- **Project number:** 5UH3DA047720-04
- **Recipient organization:** NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
- **Principal Investigator:** ADAM BISAGA
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $4,087,023
- **Award type:** 5
- **Project period:** 2018-09-15 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10366089

## Citation

> US National Institutes of Health, RePORTER application 10366089, Evaluation of safety and pharmacokinetics of naltrexone implant (5UH3DA047720-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10366089. Licensed CC0.

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