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# New Endpoint Option for Alcohol Use Disorder
- URL: https://www.fdaweb.com/new-endpoint-option-for-alcohol-use-disorder/
- Published: 2025-02-14T12:00:00.000Z
- Updated: 2026-09-14T14:53:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158666

CDER has posted a drug development qualifying tool to support treatments for alcohol use disorder (AUD). The tool is based on a two-level reduction in risk drinking level (RDL) of alcohol consumption and was validated as clinically meaningful, the Center says, adding that it can serve as an acceptable primary endpoint in AUD studies.

“This tool provides a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days,” it says. “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.”

CDER also provides a [qualification statement](https://force-dsc.my.site.com/ddt/s/ddt-project?ddtprojectid=33&ref=fdaweb.com) that defines the context in which FDA will accept the surrogate endpoint for regulatory decisions.