Assessment of Abuse Potential in Clinical Trials: The Finalized FDA Guidance

Categories: Abuse Potential Assessment, Blog, FDA

What does the future hold for abuse potential now that FDA has finalized the Guidance on Assessment of Abuse Potential of Drugs? Jack Henningfield, PhD, chaired a workshop at the College on Problems of Drug Dependence (CPDD) to address this topic.

“The science of abuse potential has evolved enormously in recent decades. The FDA’s 2017 Guidance captures this as applied to medicines and other substances. It provides the basis for an orderly and more predictable process for drug development and regulatory decision making.” said Dr. Henningfield. “We urge sponsors to reference the FDA guidance when planning and designing studies and to discuss alternative approaches with the Agency. Phase 3 studies, in particular, often require working within practical constraints and reliance on indirect measures such as spontaneous AE reports that might, but do not necessarily, reflect abuse, dependence or withdrawal.”

Workshop topics included:

  • The process of documenting abuse-related signals from clinical trials, Silvia Calderon, Pharmacologist, Controlled Substances Staff, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Development of a standardized classification system for assessing abuse potential in clinical trials: ACTTION recommended considerations, Shannon Smith, Assistant Professor of Anesthesiology, University of Rochester School of Medicine and Dentistry
  • Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®), Nathaniel Katz, CEO, Analgesic Solutions
  • Assessing abuse potential from soup to nuts: Nonclinical and clinical study data that inform label claims and CSA scheduling recommendations, Katherine Bonson, Pharmacologist, Controlled Substances Staff, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Dr. Henningfield’s presentation can be found here.

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