EXCLUSIVE: After FDA Response, Adial Starts Manufacturing Clinical Supplies For Upcoming Phase 3 Program Of Lead Candidate For Alcohol Use Disorder

On Tuesday, Adial Pharmaceuticals, Inc. ADIL announced a positive response from the U.S. Food and Drug Administration (FDA) regarding its proposed in vitro bridging strategy for AD04.

The FDA's feedback follows Adial's submission in November 2024, in which the company sought FDA's guidance on the alignment of its AD04 formulation strategy and bridging approach.

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The company also aimed to secure confirmation from the FDA that its proposed data package would meet the necessary bridging requirements and allow for the progression of AD04 into Phase 3 trials.

In response, the FDA agreed with Adial's proposed 505(b)(2) bridging strategy, which involves leveraging the results from AD04-103—a relative bioavailability food-effect study—along with in vitro dissolution data demonstrating equivalence between the reference product and the planned commercial formulation of AD04.

While the final determination will depend on a comprehensive review of the complete New Drug Application (NDA), the FDA's agreement signals a significant regulatory milestone for Adial.

With this regulatory confirmation, Adial is manufacturing clinical supply materials in preparation for its upcoming Phase 3 program in 2025.

In January, Adial Pharmaceuticals completed an AD04-103 pharmacokinetics (PK) study for AD04, confirming predictable bioavailability, dose proportionality, no food effect, and a safety profile consistent with ondansetron's use.

Results confirmed ondansetron exposure increased proportionally across AD04 doses and can be taken with or without food.

These results enable an End-of-Phase 2 (EOP2) FDA interaction to finalize the Phase 3 trial design and support ongoing partnership discussions.

Price Action: ADIL stock is down 5.88% at $0.72 during the premarket session on last check Tuesday.

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