Adial Pharmaceuticals, Inc. (NASDAQ: ADIL), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today applauded recent U.S. Senate legislative support for expanding clinical trial endpoints beyond abstinence in substance use disorder treatments, including Alcohol Use Disorder (AUD).
The U.S. Senate’s move to encourage the Food and Drug Administration to develop new endpoints for AUD, such as reduced cravings, to enhance the regulatory pathway for new pharmaceutical candidates strongly reinforces Adial’s clinical development strategy for AD04, its lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of AUD in individuals with heavy drinking and select genotypes.
The Appropriations report, which recently advanced out of Committee on a bipartisan 26-3 vote, encourages the FDA and the National Institute on Drug Abuse (NIDA) to support alternative clinical endpoints such as reduced craving, reduced drug or alcohol use, and decreased disorder severity.
This forward-thinking perspective validates Adial’s patient-centric approach to AUD treatment and promotes a more supportive regulatory environment for AD04’s continued development.
By moving beyond abstinence as the singular measure of success, the new legislative language reflects real-world patient focused recovery patterns and offers an evidence-based path forward for evaluating treatments like AD04. AD04 is intended to help patients reduce alcohol intake and cravings, making it uniquely positioned to benefit from the Committee’s call for more relevant, patient-focused clinical trial endpoints.
ADIL shares rose 0.16% to 37 cents.
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