NIH-funded research U01 cooperative agreement

Development of a new opioid with protection against overdose

Official title: PF614-MPAR: clinical development of opioid with oral overdose protection

Funded at Ensysce Biosciences, INC. · NIH-11176951 · Data updated 2026-11-12

This study is testing a new kind of opioid medication designed to help manage pain while also reducing the chances of overdose and misuse, making it a safer option for people dealing with moderate-to-severe pain who are worried about addiction.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionEnsysce Biosciences, INC.
NIH-funded
Lab location1 site (La Jolla, United States)
Project startSeptember 1, 2024
Project endMay 31, 2027
Funding year2025
Award (this year)$5,288,921
NIH project number5U01DA059791-02
Project IDNIH-11176951 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates for this research are individuals suffering from moderate-to-severe pain who may require opioid treatment but are concerned about the risks associated with traditional opioids.

Less likely to help

Patients who do not experience moderate-to-severe pain or those who are not candidates for opioid therapy may not benefit from this research.

What this research studies

This research focuses on creating a new type of opioid medication that includes built-in protections against overdose and abuse. The approach involves a novel combination of technologies that modify the opioid's chemical structure to control its release and deter misuse. By using a prodrug formulation that activates only in the presence of specific enzymes, the medication aims to provide effective pain relief while minimizing the risk of addiction and overdose. Patients with moderate-to-severe pain who are concerned about opioid misuse may find this new treatment option beneficial.

Why it matters

Potential benefit: If successful, this research could provide a safer opioid option that effectively manages pain while reducing the risk of addiction and overdose.

How similar studies have gone: While there are existing abuse-deterrent opioid formulations, this approach is novel as it incorporates chemical modifications rather than just formulation changes, aiming to provide enhanced protection against misuse.

Where this research is happening

  • Ensysce Biosciences, INC.
    La Jolla, United States
    Active

Researchers

  • Principal investigator: Kirkpatrick, Lynn — Ensysce Biosciences, INC.
  • Study coordinator: Kirkpatrick, Lynn

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.