The U.S. Food and Drug Administration has qualified a drug development tool to facilitate clinical trial research on alcohol use disorder.

The tool, developed by the Center for Drug Evaluation and Research, is based on a two-level reduction in risk drinking level (RDL) and has been validated as a clinically meaningful endpoint for assessing treatment efficacy in patients with moderate to severe alcohol use disorder (AUD). This qualification establishes the two-level RDL reduction as an acceptable primary endpoint in clinical trials evaluating pharmacologic interventions for AUD, the Food and Drug Administration (FDA) described in a statement published on February 14, 2025.

The need for expanded therapeutic options for AUD remains substantial. In 2023, an estimated 28.9 million individuals in the U.S. met criteria for AUD, according to the Substance Abuse and Mental Health Services Administration. Historically, clinical trials for AUD pharmacotherapies have relied on abstinence or no heavy drinking days as primary endpoints. The FDA's qualification of the two-level RDL reduction provides a validated alternative endpoint for assessing reductions in alcohol consumption, which may improve clinical trial feasibility for AUD treatments.

This regulatory qualification allows investigators to evaluate treatment efficacy based on whether an intervention achieves a two-level reduction in RDL. The qualification statement defines the specific context in which this endpoint will be accepted by the FDA and offers clarity for drug developers seeking approval for AUD therapies.

The use of drug development tools supports new therapies by providing standardized biomarkers, clinical outcome assessments, and certain animal models to aid regulatory review and trial design. This qualification may streamline clinical trial design for AUD treatments.