New Reduced Drinking Goals in Alcohol Pharmacotherapy Trials—A Novel Public-Private Effort and FDA Approval Process

Raymond F. Anton; Stephanie S. O’Malley; Karl Mann; Bernard L. Silverman

doi:10.1001/jamapsychiatry.2025.2515

September 17, 2025JAMA Psychiatry

New Reduced Drinking Goals in Alcohol Pharmacotherapy Trials—A Novel Public-Private Effort and FDA Approval Process

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Key Points

Establishing reduced drinking levels as clinical trial endpoints may improve alcohol use disorder treatment outcomes.
This initiative involves collaboration between public and private sectors, paving the way for new FDA approval processes.
Using innovative endpoints could transform how alcohol use disorder treatments are evaluated and approved.
Confirming reduced drinking levels as benchmarks could lead to more effective interventions for those with alcohol dependence.

Implication

This viewpoint reveals a unique public-private partnership to set reduced drinking levels as an endpoint in alcohol use disorder clinical trials, suggesting FDA approval processes may evolve.

Abstract

This Viewpoint describes the work of a public-private partnership to establish a reduced drinking level–based end point for clinical trials of alcohol use disorder treatment.

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Cite This Study

Anton et al. (2025) studied this question.

synapsesocial.com/papers/68d461c231b076d99fa60ee9 https://doi.org/10.1001/jamapsychiatry.2025.2515

View Full Paper

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New Reduced Drinking Goals in Alcohol Pharmacotherapy Trials—A Novel Public-Private Effort and FDA Approval Process

Key Points

Implication

Abstract

Discussion

Cite This Study

New Reduced Drinking Goals in Alcohol Pharmacotherapy Trials—A Novel Public-Private Effort and FDA Approval Process

Key Points

Implication

Abstract

Discussion

Cite This Study

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