# Novel opioids that protect against oral overdose and disrupt the progression to misuse, abuse, and addiction

> **NIH NIH R01** · ELYSIUM THERAPEUTICS, INC. · 2020 · $2,677,544

## Abstract

Project(Summary(/(Abstract(
The abuse of prescription drugs is the fastest-growing drug problem in the United States,
and reducing such abuse is a national priority. In 2014, prescription opioids caused
18,893 overdose deaths in the United States, according to the American Society of
Addiction Medicine.
The best way to defeat an epidemic is to reduce exposure. In this case, the challenge is
to reduce exposure without compromising patient care. This calls for a balanced solution
that addresses both the individual patient's needs and the national opioid epidemic.
Elysium’s O2P (oral overdose protection) technology is designed to provide such a
balanced solution by taking advantage of the well-established efficacy of existing
opioids, while protecting against abuse and fatal overdose. Using novel chemistry, we
have created a new class of immediate-release (IR) oral opioids that offer an attractive
alternative to the widely-prescribed Vicodin®, Percocet®, Lortab®, Norco®, etc. with
superior tamper resistance and unprecedented protection from oral overdose that could:
· Save thousands of lives each year;
· Disrupt the heartbreaking and often lethal progression from the misuse and
 abuse of prescription opioids, to heroin use and addiction; and
· Provide safe pain relief to patients throughout the world that currently do not
 have access to effective opioid-based pain therapy due to fears relating to abuse
 and overdose.
With NIH and NIDA’s support (1R44DA037900), Elysium has successfully achieved in
vivo proof-of-concept. The overall goal of this proposed grant is to collaborate with a
Strategic Alliance of highly qualified CROs and scientific advisers to accelerate
development of our O2P IR hydrocodone product candidate through Phase 1 human
proof of concept studies, a pivotal step toward advancing our lead toward FDA approval,
and a commercialization deal with a larger pharmaceutical company.

## Key facts

- **NIH application ID:** 9717217
- **Project number:** 5R01DA046102-02
- **Recipient organization:** ELYSIUM THERAPEUTICS, INC.
- **Principal Investigator:** Thomas E Jenkins
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,677,544
- **Award type:** 5
- **Project period:** 2018-06-15 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9717217

## Citation

> US National Institutes of Health, RePORTER application 9717217, Novel opioids that protect against oral overdose and disrupt the progression to misuse, abuse, and addiction (5R01DA046102-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9717217. Licensed CC0.

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