[2/14/2025] FDA's Center for Drug Evaluation and Research (CDER) has a qualifying tool to support the development of treatments for alcohol use disorder (AUD).
Innovation in treatment development for AUD is greatly needed, as the Substance Abuse and Mental Health Services Administration estimated 28.9 million Americans had an AUD in 2023. The new tool is based on a two-level reduction in risk drinking level (RDL) of alcohol consumption and was validated as clinically meaningful. As a result, it can be used as an acceptable primary endpoint in studies of medications to treat adults with moderate to severe AUD.
This tool provides a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days. With this qualification, investigators can now determine if their proposed treatment works as they expect based on whether it reduced RDLs by two levels in clinical trials.
The two-level reduction in risk drinking levels validates the clinical significance of reductions in drinking, an important goal for many patients. This qualification provides a tool that may enhance the feasibility of trials for AUD, which we hope will facilitate drug development.
The qualification statement completes the review of the full qualification package and defines the context in which FDA will accept the surrogate endpoint for regulatory decisions.
Drug development tools play an important role in bringing new therapies to the market. They include biomarkers, which are defined biological characteristics; clinical outcome assessments, which describe how patients feel, function, or survive; and certain animal models.
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