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Adial Pharmaceuticals Files for Expedited Review of AD04 with the FDA
CHARLOTTESVILLE, VA / ACCESSWIRE / September 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"CHARLOTTESVILLE, VA / ACCESSWIRE / September 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has submitted a formal request to the U.S. Food and Drug Administration (FDA) in support of Adial's position that AD04 should be considered eligible for an FDA expedited review program. Adial's lead drug candidate, AD04, is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes and the Company and regulatory advisors have concluded that AD04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.William Stilley, Chief Executive Officer of Adial Pharmaceuticals, stated, \"We are making rapid progress enrolling patients in our landmark ONWARD™ pivotal Phase 3 clinical trial of AD04. Sadly, now more than ever, the AUD crisis continues to escalate. As recently reported by the NIAAA, ‘the COVID-19 pandemic has increased stress for people worldwide, with millions experiencing prolonged periods of fear, anxiety and social isolation - conditions that are known to increase craving, consumption, and risk of relapse in individuals with alcohol and substance use disorders.' AD04 is designed to address this serious condition for which existing treatment options have low retention rates and potentially inferior safety profiles. Given the significant results of our Phase 2 trial, the progress of our Phase 3 trial, and the gravity of the social and economic impacts of alcohol use disorder, exacerbated by this pandemic, we believe this is the appropriate time to seek FDA expedited review of AD04.\"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 be identified using the Company's proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising resul...