# I-Corps: Longer-acting intravaginal formulation of buprenorphine

> **NIH NIH R44** · AURITEC PHARMACEUTICALS, INC. · 2021 · $54,916

## Abstract

PROJECT SUMMARY
The broad, long-term goal of this research program is to empower women suffering from opioid use disorder
(OUD) through the development of a long-acting intravaginal ring (IVR) formulation of the opioid partial agonist
-buprenorphine (BUP). The fast-track proposal was submitted in response to RFA-DA-19-019 which calls for
solutions to develop “Longer-acting formulations of existing addiction medications”.
The current armamentarium of BUP-based drug products for the treatment of OUD includes daily sublingual,
monthly injectable, and bi-annual implantable formulations. The year-over-year increase in these prescriptions
suggest that improved BUP medications hold significant potential for improving patient retention, and overall
healthcare outcomes.
Despite their usefulness, both immediate-release and long-acting BUP formulations demonstrate sub-optimal
pharmacokinetic (PK) profiles displaying an initial burst release followed by plateauing. The daily formulations
often suffer from adherence/compliance issues and contain 5-10X more drug loading than required, creating
diversion potential. Long-acting injectable and implantable medications are invasive, and require HCP visits for
administration. To address this unmet need, we propose a “fast-track” IND-enabling approach to develop a
monthly IVR delivering BUP using our established drug delivery technology.
The commercial success of the contraceptive IVR Nuvaring® provides an applicable case study. More than 1
million women choose IVRs over traditional methods: more than long-acting implants or patches. We expect
that a BUP ring will be chosen by a significant percentage of women seeking treatment for OUD.
Our team has experience formulating IVRs to deliver a wide variety of small and large molecules using our
“pod” technology. This work has resulted in three IND approvals in the fields of HIV pre-exposure prophylaxis
(PrEP) and the treatment of genital herpes. In preliminary work, we developed a pilot BUP pod-IVR and tested
it in vitro to confirm its formulation feasibility. We confirmed that BUP is vaginally bioavailable in an animal
model. PK modeling indicates that our pod-IVR can maintain therapeutic plasma levels at a substantially
reduced dose and diversion potential.
The specific aims of Phase 1 are to develop lead formulations across a broad range of release targets and to
perform safety and PK testing in animals. The milestone for successful completion of Phase 1 will be the
demonstration of safety and clinically relevant drug concentrations from the animal study.
In Phase 2, the specific aims will be: to carry out all of the necessary work in chemistry, manufacturing and
controls (CMC); pre-clinical animal studies; and protocol development to allow the milestone: Investigational
New Drug (IND) allowance from the FDA allowing the first-in-human testing of a BUP pod-IVR.
Following successful completion of this project, we will seek funding to carry out a series of clinical stud...

## Key facts

- **NIH application ID:** 10337527
- **Project number:** 3R44DA053073-01S1
- **Recipient organization:** AURITEC PHARMACEUTICALS, INC.
- **Principal Investigator:** Thomas J. Smith
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $54,916
- **Award type:** 3
- **Project period:** 2020-09-30 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10337527

## Citation

> US National Institutes of Health, RePORTER application 10337527, I-Corps: Longer-acting intravaginal formulation of buprenorphine (3R44DA053073-01S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10337527. Licensed CC0.

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