# Development of Sudaxine for the Treatment of Opioid Induced Respiratory Depression (OIRD) in the Peri-operative Hospital Setting

> **NIH NIH R44** · ATELERIX LIFE SCIENCES INC. · 2022 · $908,519

## Abstract

PROJECT SUMMARY
Opioid-induced respiratory depression (OIRD) is a potentially fatal complication of treatment with opioids. In the
peri-operative setting, opioids are widely used to provide analgesia and supplement sedation during general
anesthesia or monitored anesthesia care. However, over 46% of surgical patients receiving opioids will
experience OIRD ranging from problematic to life-threatening. The use of naloxone, an opioid receptor
antagonist that is effective at reversing OIRD, is limited in the peri-operative setting because it also reverses the
pain relief provided by the opioid. Thus, there remains a critical need to develop a therapeutic that can reverse
OIRD while maintaining the analgesic efficacy of classical opioid analgesics.
Atelerix Life Sciences’ solution to OIRD in the peri-operative care setting is Sudaxine, a novel small molecule
therapeutic that selectively targets signaling pathways downstream of activated opioid receptors to alleviate
OIRD without reversing analgesia. We have already progressed Sudaxine through early preclinical studies
including in vivo efficacy and safety testing, and pharmacodynamic and pharmacokinetic testing. Our results
have demonstrated that Sudaxine is safe (no adverse cardiorespiratory or thermoregulatory effects) and that this
targeted approach leads to reversal of OIRD without blunting analgesia. Thus, Sudaxine has the potential to
disrupt the current standard of care for OIRD in the peri-operative setting.
In this Direct to Phase II project, Atelerix will focus on additional preclinical testing and manufacturing steps
required to facilitate IND-submission and future clinical trials. This will be accomplished through the execution of
four Aims. In Aim 1, we will evaluate the toxicity of Sudaxine by conducting a non-GLP single dose toxicity and
toxicokinetic study in dogs. In Aim 2, we will conduct a drug-drug interaction screen. In Aim 3, we will conduct
IND-enabling GLP genotoxicity, safety pharmacology, and toxicology studies. Aim 4 will focus on manufacturing
GMP-grade Sudaxine drug substance. A successful outcome of the project will lead to a disruptive and greatly
needed therapeutic solution for the treatment of OIRD in the peri-operative hospital setting. The proposed work
will lay the foundation for the development of additional novel respiratory stimulants that can have broader
applications beyond peri-operative care and ultimately unleash the greater potential of Sudaxine to target unmet
needs associated with the opioid crisis.

## Key facts

- **NIH application ID:** 10546160
- **Project number:** 1R44HL164201-01A1
- **Recipient organization:** ATELERIX LIFE SCIENCES INC.
- **Principal Investigator:** JAMES N BATES
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $908,519
- **Award type:** 1
- **Project period:** 2022-09-20 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10546160

## Citation

> US National Institutes of Health, RePORTER application 10546160, Development of Sudaxine for the Treatment of Opioid Induced Respiratory Depression (OIRD) in the Peri-operative Hospital Setting (1R44HL164201-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10546160. Licensed CC0.

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