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Adial Pharmaceuticals Announces FDA Reactivation of its Investigational New Drug Application for AD04 in Alcohol Use Disorder
CHARLOTTESVILLE, VA / ACCESSWIRE / October 21, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"CHARLOTTESVILLE, VA / ACCESSWIRE / October 21, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the U.S. Food and Drug Administration (FDA) has reactivated Adial's U.S. Investigational New Drug (IND) application and lifted the clinical hold from AD04, a genetically-targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). The IND had been on clinical hold due to insufficient manufacturing information at the time the IND was inactivated by the Company, which was done while the Company exclusively focused its efforts on the Company's landmark ONWARD™ pivotal Phase 3 clinical trial in Europe. The manufacturing data was developed and submitted to the relevant European regulatory authorities prior to commencing the ONWARD™ trial. However, since the trial was not being conducted in the U.S., the data had not yet been submitted to the FDA.Reactivation of Adial's IND allows the Company to continue its pursuit of U.S. expedited review programs for AD04 and for the initiation of a planned Phase 1 pharmacokinetics (PK) clinical study in the U.S., which is intended to be supportive of a New Drug Application (NDA) submission with the FDA.William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, \"Given the prolonged nature of the COVID-19 pandemic, the AUD crisis continues to escalate. For this reason, we have filed for an expedited review of AD04 with the FDA. The acceptance of our manufacturing data, as well as our plan for the proposed clinical study, marks an important milestone as we progress towards evaluating AD04 clinically in the United States. We continue to enroll patients in our landmark ONWARD™ pivotal Phase 3 clinical trial of AD04 in Europe and look forward to providing further updates as our progress continues.\"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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical for the potential treatment of AUD in subjects with certain target genotypes, which are to ...