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

A Mattawan pilot provided preliminary proof of concept for the approach the collaboration will evaluate.

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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.

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Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com

Charles River Media Contact:
Amy Cianciaruso
Corporate Senior Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

Key Terms

abuse-deterrent formulations medical

Drug formulations engineered to reduce the likelihood or ease of misuse by making common methods of tampering and non-prescribed use harder or less rewarding; examples of deterrent features include physical barriers that resist crushing or dissolving, added substances that produce unpleasant effects if the product is altered, incorporation of blockers (opioid antagonists) that activate when the product is manipulated, or delivery designs that limit rapid release. These features address specific routes of abuse (for example, snorting or injecting) but do not make a medicine abuse-proof, and they do not change the approved medical use or the underlying addiction risk of the active drug.

controlled substances act regulatory

A federal law that creates the rules for which drugs and chemicals are legal, how they are classified by risk, and what licenses and controls are required for manufacture, distribution, research, and medical use. For investors, these classifications act like traffic signals — they determine how easy or hard it is for companies to develop, sell, or research certain medications and can sharply affect a company’s regulatory cost, market access, and legal risk.

central nervous system-active compounds medical

Compounds that produce their primary biological effects by acting on the central nervous system (the brain and spinal cord), typically by interacting with neuronal targets such as neurotransmitter systems, receptors, ion channels or enzymes. Many CNS‑active compounds must reach the brain or spinal cord (often by crossing the blood–brain barrier) and are used or studied for effects on mood, cognition, perception, movement, pain or autonomic control; the label describes a pharmacological action, not a specific medical use or safety profile.

self-administration data technical

Data recorded when patients or study participants administer a medicine, medical device, or diagnostic procedure themselves rather than in a clinic. It includes timing and dose information, symptom or side-effect reports, device-read logs, and adherence records gathered via paper/electronic diaries, apps, wearable sensors, or remote monitoring systems; regulators and sponsors use these data to assess real‑world use, safety, and adherence but must account for potential inaccuracies from self-reporting, device errors, or incomplete capture.