University awarded $12 million to further develop opioid use disorder drug

Credit: Ernesto del Aguila III, NHGRI

Charles  P.  France, PhD, to lead methocinnamox drug development program

The University of Texas Health Science Center at San Antonio (UT Health San Antonio) was awarded a $12 million cooperative agreement (U01) from the National Institutes of Health’s National Institute on Drug Abuse to further develop methocinnamox (MCAM) as a treatment for opioid use disorder. MCAM is a mu opioid receptor antagonist with a long duration of action that blocks the effects of opioids like fentanyl, heroin and oxycodone.

Charles P. France, PhD

Charles P. France, PhD, professor of pharmacology and psychiatry, Robert A. Welch Distinguished University Chair with the Joe R. and Teresa Lozano Long School of Medicine, is a leading expert on MCAM and is heading this drug development program.

This award will support the manufacture of MCAM for clinical trials, submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) and potentially a Phase 1 clinical trial.

France has studied MCAM for the past seven years at UT Health San Antonio. He said the goals in the next phase of development are ambitious but achievable.

His laboratory will oversee the project and conduct additional basic research while separate companies will manufacture MCAM and manage clinical trials.

“Making a compound in gram or milligram quantities is one thing, but to scale it up brings in a whole different set of challenges,” France said. Over the past several years the synthesis of MCAM was significantly improved and scaled up to kilogram quantities.

France said they expect to have the required MCAM material manufactured near the end of 2024 and then have the IND application submitted in early 2025. A clinical trial could possibly begin 30 days after submission of the IND application.

“We are very optimistic about having a good IND package and moving forward with clinical trials,” France said. Thanks in part to support from colleagues who are experts in the drug development process, the project has had a great deal of momentum and moved along rather quickly, he said.

France currently has one patent in place and three pending for various aspects of MCAM.

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Read more about MCAM:

Long-lasting treatment drug could slow the opioid crisis

UT Health San Antonio Professor France leads novel drug discovery research



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