Adial Pharmaceuticals announced on February 25, 2025, a positive response from the U.S. Food and Drug Administration (FDA) regarding its proposed in vitro bridging strategy for AD04. This feedback follows Adial’s submission on November 19, 2024, seeking guidance on its AD04 formulation strategy.
The FDA agreed with Adial’s proposed 505(b)(2) bridging strategy, which leverages results from the AD04-103 relative bioavailability food-effect study and in vitro dissolution data. This demonstrates equivalence between the reference product and the planned commercial formulation of AD04.
With this regulatory confirmation, Adial is proceeding with the manufacturing of clinical supply materials in preparation for its upcoming Phase 3 clinical program in 2025. This milestone is an essential step forward in advancing AD04 into late-stage clinical development and toward regulatory approval.
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