# Development of the novel mu-opioid receptor antagonist methocinnamox (MCAM) for preventing relapse and overdose

> **NIH NIH U01** · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · 2024 · $3,937,322

## Abstract

PROJECT SUMMARY/ABSTRACT
In response to PAR-22-202 “Grand Opportunity in Medications Development for Substance-Use Disorders
(U01 Clinical Trial Optional),” this revised application (U01DA060704) requests 3 years of support to continue
developing the novel opioid receptor antagonist methocinnamox (MCAM) for preventing opioid relapse after
detoxification. MCAM will fill an unmet need for an orally bioavailable, shelf-stable, long-acting medication for
preventing relapse. MCAM prevents and reverses the effects of µ-opioid receptor (MOR) agonists, including
ultra-potent agonists such as fentanyl, in several species and by multiple routes of administration with a single
dose being effective for >2 weeks. In vitro and in vivo studies have not identified any clinical adverse signs for
MCAM over a >3,000-fold dose range. IND-enabling safety pharmacology and toxicology studies in rats and
dogs (Charles River Laboratories) are complete and found no adverse clinical signs. Synthesis of MCAM
(Veranova) was improved, increasing the yield, maleate was determined to be a preferred salt, two 1-kilogram
batches of non-GMP MCAM were manufactured for non-clinical studies, ongoing stability studies are showing
MCAM to be shelf stable for at least 9 months, and analytical methods for manufacturing GMP MCAM are being
developed. In a pre-IND meeting in November 2023 (facilitated by Allucent), the FDA agreed with our proposed
non-clinical and clinical programs. A use patent for MCAM was issued in 2019 and 3 other patents are pending.
This application includes scientists with expertise in drug discovery and development, basic scientists who have
studied MCAM extensively, clinicians with expertise testing medications for substance use disorders, as well as
commercial CRO partners that will manufacture GMP MCAM (Veranova), synthesize deuterated MCAM
(Moravek), conduct non-clinical toxicology and safety pharmacology studies (Charles River Laboratories), and
serve as the regulatory agent to the FDA as well as manage clinical trials (Allucent; including a former senior
pharmacology/toxicology reviewer who served in the Division of Anesthesia, Addiction Medicine and Pain
Medicine, the Division that participated in the pre-IND meeting and will review the IND application). This revised
application requests 3 years of support to continue developing MCAM with the following 4 specific aims. 1)
Submit an IND for preventing relapse. 2) Complete Phase 1 and Phase 1b clinical trials with MCAM. 3) Plan a
Phase 2 clinical trial with MCAM. 4) Conduct additional non-clinical toxicology and other studies as
recommended by the FDA. Completing these aims, along with securing additional intellectual property protection
through pending US patents, will further strengthen the feasibility of developing MCAM as a medication for
preventing relapse after detoxification. Completing these aims will also significantly increase the value of this
project to potential future partners and investors who ha...

## Key facts

- **NIH application ID:** 11004905
- **Project number:** 1U01DA060704-01A1
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
- **Principal Investigator:** CHARLES P FRANCE
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $3,937,322
- **Award type:** 1
- **Project period:** 2024-08-15 → 2027-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11004905

## Citation

> US National Institutes of Health, RePORTER application 11004905, Development of the novel mu-opioid receptor antagonist methocinnamox (MCAM) for preventing relapse and overdose (1U01DA060704-01A1). Retrieved via AI Analytics 2026-06-13 from https://api.ai-analytics.org/grant/nih/11004905. Licensed CC0.

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