# The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate

> **NIH NIH UG3** · ADYNXX, INC. · 2020 · $2,858,544

## Abstract

RESEARCH & RELATED Other Project Information
Project Summary/Abstract
 This proposal is entitled “The long-term reduction of pain and opioid usage
following mastectomy and tissue expander/implant surgery with a single administration
of brivoligide, a non-opioid, disease-modifying drug candidate.” Brivoligide is a non-
opioid drug candidate that can alter the course of postoperative pain for patients most
likely to suffer increased pain and utilize more opioids following surgery. These patients
are identified in advance of surgery using the well-validated Pain Catastrophizing Scale
(PCS). A single administration of brivoligide at the time of surgery can reduce acute
postoperative pain in these patients by 30 to 40% beyond what can be achieved with
current standard of care for at least 28 days and reduce opioid utilization by 40% over a
three-month period following surgery, an amount equal to more than 90 opioid tablets (5
mg hydrocodone) per patient. Based on the patient population treatable by brivoligide,
this could translate to a reduction of up to 360 million tablets in the US annually.
 Brivoligide addresses the objective of the FOA to prevent and reduce opioid use
disorder (OUD) by reducing the need for opioid analgesia and preventing the escalation
of opioid dosing in patients at greater risk of using more opioids following surgery. To
achieve regulatory approval of brivoligide with a broad indication for the reduction of
postoperative pain in this patient population, the FDA requires evidence of brivoligide
efficacy in one orthopedic and one soft-tissue model of postoperative pain. Brivoligide
has been studied in three Phase 2 trials in patients undergoing total knee arthroplasty,
an orthopedic model of postoperative pain. Grant funding will allow studying brivoligide
in mastectomy, a soft-tissue surgery model suitable to detect long-term pain and opioid
reduction benefits. The UG3 portion of the grant will specifically fund a 126-subject,
randomized, double-blind, placebo-controlled Phase 2 trial in patients undergoing
mastectomy with immediate tissue expander or implant placement. Following an End-of-
Phase 2 meeting with the FDA, the UH3 portion will fund a subsequent pivotal Phase 3
mastectomy trial. The Phase 2 and 3 studies will focus on both pain reduction and opioid
reduction in subjects with elevated scores on the PCS.

## Key facts

- **NIH application ID:** 9833506
- **Project number:** 5UG3DA048375-02
- **Recipient organization:** ADYNXX, INC.
- **Principal Investigator:** DONALD C MANNING
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,858,544
- **Award type:** 5
- **Project period:** 2018-12-15 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9833506

## Citation

> US National Institutes of Health, RePORTER application 9833506, The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate (5UG3DA048375-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9833506. Licensed CC0.

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