FDA Backs Adial Pharmaceuticals' Strategy for AD04 Addiction Therapy

Adial Pharmaceuticals announced that the U.S. FDA has provided positive feedback on its proposed in vitro bridging strategy for AD04, a therapy under development for addiction treatment. This response follows Adial’s November 2024 submission seeking FDA guidance on aligning its formulation and bridging approach with the 505(b)(2) regulatory approval pathway. The request aimed to confirm that the proposed data package would support AD04’s transition to Phase 3 clinical trials after the AD04-103 study.

Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “This milestone is an essential step forward in our efforts to advance AD04 into Phase 3 clinical development and, ultimately, toward regulatory approval. The FDA’s confirmation of our proposed in vitro bridging strategy brings us closer to achieving our goal of delivering a new treatment option for patients struggling with addiction.”

The FDA agreed with every aspect of Adial’s strategy, a strategy that depends on all bioavailability and all dissolution data to completely show equivalence between the reference product and AD04’s commercial formulation. Even though a complete NDA review is needed for ultimate approval, this decision indicates a truly meaningful regulatory step. Adial has this clearance, so it is moving forward with manufacturing clinical supply materials for its planned Phase 3 trials in 2025. This reinforces its commitment to advancing AD04 as a potential breakthrough addiction therapy.