2026-02-04
Adial Applauds Congressional Directive Advancing Alternative Clinical Trial Endpoints for Substance Use Disorders, Strengthening Regulatory Path for AD04
GLEN ALLEN, Va., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today applauded the passage by Congress and signing into law by President Donald J. Trump of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill, 2026.The final legislation incorporates Senate Report 119-55, which includes a significant Congressional directive to the U.S. Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) to collaborate on the establishment of alternative clinical trial endpoints for medications treating substance use disorders, including Alcohol Use Disorder (AUD). The directive, titled "Alternative Clinical Trial Endpoints for Substance Use Disorders," calls for endpoints beyond abstinence that demonstrate meaningful clinical benefit.Specifically, Congress directed the FDA to consider endpoints such as reduced cravings or reduced disorder severity, where such measures reflect clinically meaningful improvement for patients. These non-abstinence-based outcomes align with the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) updated definition of recovery, which recognizes improvements in functioning and symptom reduction as valid and impactful treatment goals.Adial's lead investigational therapy, AD04, is designed to address AUD using a precision medicine approach and is aligned with these non-abstinence recovery outcomes. As federal agencies including the FDA and NIDA are now formally directed to collaborate on defining and implementing these alternative endpoints, the measures are expected to strengthen the regulatory framework for innovative therapies such as AD04."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, ...Full story available on Benzinga.com