Mass. 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. The joint research effort aims to improve abuse potential assessment tools. Moreover, it supports drug development and public health decision-making.
The partners will develop sensitive screening tools. These tools will quantify and rank the abuse potential of new drugs. They will also cover abuse-deterrent formulations (ADFs) and emerging drugs of abuse. In addition, the agreement creates a joint research framework. This framework strengthens objective, standardized metrics for quantifying abuse potential in preclinical models. Consequently, the findings 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.”
Why Abuse Potential Assessment Matters in Drug Development
Abuse potential assessments are vital components of the safety evaluation of central nervous system-active compounds. Furthermore, FDA and the Drug Enforcement Administration rely on these assessments for scheduling control measures. Therefore, objective and reproducible methods matter greatly. They advance regulatory science. They also support evidence-based decision-making.
This collaboration will evaluate approaches that could improve the consistency and sensitivity of abuse potential assessments. As a result, it contributes to broader efforts to protect public health.
Charles River’s Expertise and Behavioral Economic Models
Charles River brings extensive expertise to the partnership. The company has conducted over 100 abuse potential studies. Additionally, it has contributed to assessments of the abuse potential of 15 FDA-approved products.
In this collaboration, Charles River will leverage behavioral economic models of supply and demand. Specifically, the team will analyze self-administration data with these models. The models assess the relative reinforcing properties of substances. Thus, researchers can evaluate abuse potential and compare it with that of known drugs of abuse.
Meanwhile, a recent behavioral economics pilot took place at Charles River’s Mattawan site. The pilot delivered preliminary proof-of-concept data. These data demonstrated the promise of this approach.
Finally, the collaboration aims to improve sensitivity, accuracy, and consistency across laboratories. Ultimately, it will enhance public health. Researchers will assess the abuse potential of new drugs more reliably and effectively.
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News Source: Businesswire.com
