Feb. 23 at 7:16 PM
Adial Pharmaceuticals highlighted a recent FDA policy direction that could reduce the number of pivotal trials required for drug approval. The company referenced comments published on February 19, 2026, in The New England Journal of Medicine by FDA Commissioner Martin A. Makary and Vinay Prasad, outlining a shift in evidence standards.
Under the updated approach, drug approvals may be supported by one adequate and well-controlled clinical trial plus confirmatory evidence, rather than the historical expectation of two independent pivotal studies, when scientifically appropriate. The policy reflects modernization under Section 505(d) of the Federal Food, Drug, and Cosmetic Act, emphasizing trial quality and confirmatory support over trial quantity.
Adial noted that its Phase 3 strategy for lead candidate AD04—being developed for Alcohol Use Disorder in heavy-drinking patients—had previously assumed two pivotal trials.
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