Adial Pharmaceuticals highlights recent FDA policy, may reduce trial burden

Adial Pharmaceuticals (ADIL) highlighted recent U.S. Food and Drug Administration, FDA, policy direction described by FDA Commissioner Martin Makary, M.D., M.P.H., and Vinay Prasad, M.D., M.P.H., in a commentary published February 19, 2026, in The New England Journal of Medicine. In the article, FDA leadership outlined a shift in the agency’s default evidentiary posture under which, where scientifically appropriate, approval may be supported by one adequate and well-controlled clinical investigation plus confirmatory evidence, rather than the historic expectation 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.”