Charles River, Labcorp, and FDA Collaborate to Validate New Preclinical Methods for Abuse Potential Assessment

Joint research effort seeks to improve abuse potential assessment tools to support drug development and public health decision-making

WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) and Labcorp for developing sensitive screening tools to quantify and rank the abuse potential of new drugs, including abuse-deterrent formulations (ADFs) and emerging drugs of abuse. The agreement establishes a joint research framework to enhance objective, standardized metrics for quantifying abuse potential in preclinical models which may inform regulatory assessments of abuse potential under the Controlled Substances Act (CSA).

“Assessing abuse potential is essential for identifying risks and ensuring the safety of new drugs,” said Dr. Namandjé N. Bumpus, Chief Science and Innovation Officer, Charles River. “This collaboration will improve public health safeguards and ultimately amplify our shared efforts to protect patients and communities.”

Evaluating Abuse Potential
Abuse potential assessments are vital components of the safety evaluation of central nervous system-active compounds and are relied upon by FDA and the Drug Enforcement Administration for scheduling control measures.

Enhancing objective, reproducible methods to assess abuse potential is important for advancing regulatory science and supporting evidence-based decision-making. This collaboration will help evaluate approaches that could improve the consistency and sensitivity of abuse potential assessments, ultimately contributing to efforts to protect public health.

Charles River has extensive expertise in assessing abuse potential, having conducted over 100 abuse potential studies and contributed to assessments of the abuse potential of 15 FDA-approved products. As part of its participation in the collaboration, Charles River will leverage behavioral economic models of supply and demand to analyze self-administration data. These models assess the relative reinforcing properties of substances, helping researchers evaluate abuse potential and compare it with that of known drugs of abuse. A recent behavioral economics pilot conducted at Charles River’s Mattawan site provided preliminary proof-of-concept data that demonstrated the promise of this approach.

The collaboration aims to improve sensitivity, accuracy, and consistency across laboratories, ultimately enhancing public health by more reliably and effectively assessing the abuse potential of new drugs.

About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.