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New reduced drinking goals in alcohol pharmacotherapy trials: a novel public-private effort and FDA approval process

Heavy alcohol use is a major public health problem leading to considerable morbidity and mortality, including increased risk of heart disease, stroke, liver pathology, and many cancers. Despite the recognized health and social consequences of excess alcohol consumption and increasing knowledge of th...

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Hauptverfasser: Anton, Raymond F. (VerfasserIn) , O’Malley, Stephanie S. (VerfasserIn) , Mann, Karl (VerfasserIn) , Silverman, Bernard L. (VerfasserIn)
Dokumenttyp: Article (Journal) Editorial
Sprache:Englisch
Veröffentlicht: September 17, 2025
In: JAMA psychiatry
Year: 2025, Jahrgang: 82, Heft: 12
ISSN:2168-6238
DOI:10.1001/jamapsychiatry.2025.2515
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1001/jamapsychiatry.2025.2515
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Verfasserangaben:Raymond F. Anton, Stephanie S. O’Malley, Karl Mann, Bernard L. Silverman

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520 |a Heavy alcohol use is a major public health problem leading to considerable morbidity and mortality, including increased risk of heart disease, stroke, liver pathology, and many cancers. Despite the recognized health and social consequences of excess alcohol consumption and increasing knowledge of the neuroscience behind the development and maintenance of alcohol use disorder (AUD), few medications have been approved by regulatory agencies for its treatment. To address this gap, the Alcohol Clinical Trials Initiative (ACTIVE) was formed in 2012 after an initial meeting attended by academic experts, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the US Food and Drug Administration (FDA), and pharmaceutical companies to discuss ways to enhance drug development for AUD treatment. The goal of ACTIVE has been to evaluate and improve AUD clinical trial methods in a data-based manner that might inform regulatory guidance. Support for ACTIVE was funded by the pharmaceutical industry (over time by approximately 19 companies) with in-kind support and attendance by the FDA and NIAAA. As such, a public-private partnership was initiated consistent with the goals of the FDA Critical Path Initiative meant to benefit public health by improving and streamlining clinical trials. 
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