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Adial Pharmaceuticals Confirms Scheduling of Meetings with FDA and European Regulatory Agencies to Advance Clinical Development of AD04 for Alcohol Use Disorder
Type C meeting with FDA set for Second Quarter Plans in Place to Meet with Multiple Regulatory Agencies Throughout Europe CHARLOTTESVILLE, Va., Feb. 21, 2023
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"Type C meeting with FDA set for Second Quarter Plans in Place to Meet with Multiple Regulatory Agencies Throughout Europe CHARLOTTESVILLE, Va., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it has secured meetings with regulatory authorities in the U.S. and Europe to discuss and develop plans for the clinical advancement of AD04 for alcohol use disorder toward potential approvals. In the United States, Adial has secured a Type C meeting with the Food and Drug Administration (FDA) in the second quarter of this year. This meeting will allow Adial and the FDA to discuss the clinical development program for AD04 in the U.S. and the most appropriate path toward possible approval. In Europe, Adial has meetings scheduled or planned with five national regulatory authorities in France, Sweden, Finland, the United Kingdom and Germany. Adial intends to seek from the agencies a clear understanding and direction toward the most expeditious path to approval. Cary Claiborne, Adial’s President and Chief Executive Officer, said, “These meetings are the next step in our plan to complete clinical development of AD04 and bring to market a much-needed treatment for alcohol use disorder. In parallel, we are discussing opportunities with prospective pharmaceutical company partners that can help us to fund clinical development while also creating go-to market commercial strategies in the U.S. and Europe. We will provide an in-depth update on all AD04 program activities in the coming weeks.” About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company’s companion diagnost...