Adial Applauds U.S. Law Directing FDA To Expand Trial Endpoints For Addiction Drugs, Law Pushing NIDA Toward New Measures For Alcohol Use Disorder Therapies

Adial Pharmaceuticals welcomed the passage of the U.S. government’s 2026 appropriations bill covering the Departments of Labor, Health and Human Services, and Education, which was approved by Congress and signed into law by President Donald J. Trump. The legislation includes a notable policy directive aimed at reshaping how treatments for substance use disorders are evaluated in clinical trials.

Within the bill, Senate Report 119-55 instructs the U.S. Food and Drug Administration and the National Institute on Drug Abuse to jointly develop alternative clinical trial endpoints for addiction therapies, including those for Alcohol Use Disorder. Rather than relying solely on abstinence as a measure of success, the directive encourages endpoints that capture meaningful patient benefit, such as reduced cravings or lower disease severity, outcomes that reflect real-world improvement in daily functioning.

“This Congressional directive reflects a meaningful evolution in how substance use disorders are evaluated and treated,” said Cary Claiborne, President and Chief Executive Officer of Adial. “By embracing endpoints that recognize real-world clinical improvement beyond abstinence alone, policymakers are helping to modernize regulatory expectations and support innovation. We believe this action enhances the regulatory path for AD04 and reinforces Adial’s strategy to address the substantial unmet need in AUD with precision-based therapies.”

These proposed measures mirror the National Institute on Alcohol Abuse and Alcoholism’s evolving definition of recovery, which recognizes symptom reduction and improved quality of life as legitimate treatment goals. Adial highlighted that its lead investigational candidate, AD04, is designed around this precision-medicine approach and is already aligned with such non-abstinence-based outcomes.

Given the scale of Alcohol Use Disorder and the limited effectiveness of current therapies, Adial believes the new regulatory guidance could help speed development timelines and create a clearer approval pathway for innovative treatments. The company sees the directive as a meaningful step toward modernizing addiction medicine and expanding options for patients in need.