Adial Pharmaceuticals Receives Positive FDA Feedback on In Vitro Bridging Strategy for AD04

Adial Pharmaceuticals (NASDAQ: ADIL) announced that it received positive feedback from the U.S. Food and Drug Administration (FDA) on its proposed in vitro bridging strategy for its drug candidate AD04. The feedback, which was provided on February 25, 2025, affirms the company’s regulatory approach under the 505(b)(2) pathway as it prepares for its upcoming Phase 3 clinical program.

The strategy, detailed in filings made on the same day, builds on the results from the AD04-103 study—a pivotal relative bioavailability and food-effect trial. In its submission dated November 19, 2024, the company sought guidance on aligning its AD04 formulation with the planned commercial product and ensuring that the data package would fulfill the necessary bridging requirements for the New Drug Application.

According to the company’s press release, the FDA’s acceptance of the proposed bridging strategy confirms that a combination of data from the AD04-103 clinical study and in vitro dissolution tests will support an equivalence assessment between the reference product and the commercial formulation. While the Agency’s final determination will depend on a comprehensive review of the complete NDA, this step marks an important regulatory milestone for Adial as it advances its development plans.

With regulatory confirmation in hand, Adial is moving forward with the manufacturing of clinical supplies in preparation for its anticipated Phase 3 trials later this year. The company’s strategy aims to streamline the drug development process while addressing the significant unmet need in treating addiction, including alcohol use disorder and other related conditions.

Adial’s approach reflects its commitment to closely collaborating with regulatory authorities to ensure compliance and expedite the development of therapies for addiction. The positive response from the FDA is expected to bolster the company’s efforts to advance AD04 toward eventual regulatory approval, marking a notable step in its ongoing clinical-stage development.

Investors and industry observers will be watching closely as Adial progresses into the next phase of its clinical program, aiming to provide new treatment options for patients battling addiction.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Adial Pharmaceuticals’s 8K filing here.

About Adial Pharmaceuticals

Adial Pharmaceuticals, Inc, a clinical-stage biopharmaceutical company, focuses on the development of therapeutics for the treatment or prevention of addiction and related disorders. Its lead product is AD04, a serotonin-3 antagonist, which is in Phase III clinical trial for the treatment of alcohol use disorder.