Patient - centric approach to AUD treatment
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Adial Pharmaceuticals Encouraged By U.S. Senate Support for Expanded Clinical Trial Endpoints Beyond Abstinence in Alcohol and Substance Use Disorder Treatments
Globenewswireยท 2025-08-20 12:30
Core Insights - The U.S. Senate has shown legislative support for expanding clinical trial endpoints in substance use disorder treatments, particularly for Alcohol Use Disorder (AUD), which aligns with Adial Pharmaceuticals' strategy for its investigational drug AD04 [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with its lead investigational drug AD04 targeting AUD [4] - AD04 is a serotonin-3 receptor antagonist that has shown promising results in a Phase 3 clinical trial, demonstrating reduced drinking in patients with AUD and good tolerability [4] Legislative Support - The Senate Appropriations report encourages the FDA and NIDA to support alternative clinical endpoints such as reduced cravings and decreased disorder severity, validating Adial's patient-centric approach [2][3] - This legislative momentum reflects a shift towards recognizing real-world recovery patterns and offers a more supportive regulatory environment for the development of AD04 [2][3] Clinical Development Strategy - The new legislative language promotes a broader definition of success in AUD treatment, moving beyond abstinence to include measures like reduced cravings, which aligns with the goals of AD04 [2][3] - Cary Claiborne, CEO of Adial Pharmaceuticals, emphasized the unmet medical need for new AUD therapies and the alignment of science, patient needs, and regulatory vision [3]