Adial Pharmaceuticals Applauds U.S. Senate Support for Expanded Clinical Trial Endpoints in Substance Use Disorder Treatments.

Adial Pharmaceuticals (ADIL) welcomes U.S. Senate support for extended AUD trial endpoints, aligning with their strategy for AD04, a serotonin-3 receptor antagonist for Alcohol Use Disorder treatment. The Senate's move to encourage FDA to develop new endpoints for AUD enhances the regulatory pathway for new pharmaceutical candidates.

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) has expressed satisfaction with recent U.S. Senate legislative support for expanding clinical trial endpoints beyond abstinence in substance use disorder treatments, including Alcohol Use Disorder (AUD). The Senate's move to encourage the FDA to develop new endpoints, such as reduced cravings, aligns with Adial's clinical development strategy for AD04, its lead investigational drug for AUD treatment.

The U.S. Senate's Appropriations report, which passed with a bipartisan vote, urges the FDA and 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 shift reflects a more patient-centric approach to AUD treatment and promotes a more supportive regulatory environment for AD04's continued development.

AD04, a serotonin-3 receptor antagonist, is designed 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. The new legislative language validates Adial's patient-centric approach and offers an evidence-based path forward for evaluating treatments like AD04.

"We are encouraged by this legislative momentum, which mirrors the very foundation of our AD04 program," said Cary Claiborne, CEO of Adial Pharmaceuticals. "Our therapy is designed to reduce cravings and harmful alcohol consumption, rather than enforce an all-or-nothing abstinence model. As the U.S. Senate report makes clear, there is tremendous unmet medical need for new AUD therapies. This legislative directive signals meaningful change and momentum—one that brings the science, patient needs, and regulatory vision into closer alignment."

Adial's AD04, which showed promising results in a Phase 3 clinical trial, is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. The company continues to focus on developing strategic partnerships and maintaining collaborations to advance its product candidates.

References:
[1] https://www.morningstar.com/news/globe-newswire/9515172/adial-pharmaceuticals-encouraged-by-us-senate-support-for-expanded-clinical-trial-endpoints-beyond-abstinence-in-alcohol-and-substance-use-disorder-treatments
[2] https://www.stocktitan.net/news/ALT/altimmune-announces-fda-fast-track-designation-for-pemvidutide-in-zkb42azg36ea.html