Adial Pharmaceuticals Cites FDA Policy Shift Supporting Flexible Evidentiary Standards For Drug Approval

Adial Pharmaceuticals, Inc. highlighted recent policy direction from the U.S. Food and Drug Administration, as outlined in a February 19, 2026, commentary published in The New England Journal of Medicine by FDA Commissioner Martin A. Makary and Vinay Prasad. The commentary described a shift in the agency’s evidentiary framework, indicating that, when scientifically appropriate, drug approvals may be supported by one adequate and well-controlled clinical trial plus confirmatory evidence, rather than the traditional requirement of two independent pivotal studies.

Cary Claiborne, President and Chief Executive Officer of Adial Pharmaceuticals, stated, “FDA’s policy direction confirming that, under appropriate scientific circumstances, approval may be supported by one adequate and well-controlled clinical investigation plus confirmatory evidence is a potentially transformative development for Adial. Historically, our Phase 3 strategy contemplated two pivotal trials, which represent the most expensive and time-intensive stage of drug development. If AD04 can ultimately be advanced under a one-study framework, the impact could be substantial – significantly lowering Phase 3 costs, improving overall capital efficiency, and accelerating our path toward NDA submission, without compromising agency standards. For a late-stage clinical program like AD04, that type of regulatory modernisation meaningfully enhances the strategic and economic profile of the asset.”

According to the FDA leadership, the updated approach reflects a modernisation of regulatory standards, placing greater emphasis on the quality of clinical evidence and supportive data rather than the sheer number of trials conducted. The agency maintains discretion to assess each development program individually, ensuring that scientific rigour and patient safety remain central to approval decisions.

Adial’s lead investigational candidate, AD04, is a genetically targeted serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder in heavy drinking patients. As the company prepares for the next stage of clinical development, it plans to engage closely with the FDA to align on an evidentiary strategy for AD04 that reflects current regulatory standards and evolving policy considerations.