CHARLOTTESVILLE, Va., Feb. 23, 2021 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it will be filing an application for “Fast Track” with the U.S. Food and Drug Administration (FDA) for its lead drug candidate, AD04, which is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes.
Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adial’s position that AD04 should be considered eligible for an FDA expedited review program. Adial and its regulatory advisors had previously concluded that AD04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.“Adial’s correspondence and consultation with the FDA following its expedited review filing in September 2020, leads us to believe that AD04 qualifies for Fast Track consideration,” said Adial’s Head of Regulatory, Dr. Jack Reich. “I am confident Alcohol Use Disorder qualifies as a serious condition and that there is an unmet medical need, based on our communication with the FDA and as set forth in the FDA’s Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics.”“We are working with our regulatory counsel to prepare our Fast Track submission after consultation with the FDA,” commented Adial’s CEO, William Stilley. “Following our submission, the FDA is expected to review the request and make a decision within 60 days.”The FDA’s Fast Track is a process designed to facilitate development and expedite the regulatory review of drugs that treat serious conditions and address unmet medical needs with the purpose of getting important drugs to patients earlier. While the FDA judges the seriousness of a condition on a case-by-case basis, the FDA generally considers whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, left untreated, will progress to a more serious state. Depression is one such disease that is considered to be a serious condition for Fast Track purposes, and Adial believes that Alcohol Use Disorder will be treated similarly.When reviewing a Fast Track application where there are available therapies, the Fast Track drug must demonstrate advantages over the available therapy currently approved for the indication in order to be considered as meeting an unmet medical need. Examples of advantages considered by the FDA that Adial believes are applicable to AD04 include: (1) has an effect on a serious outcome of the condition in patients who are unable to tolerate or failed to respond to available therapy; (2) decreases a clinical significant toxicity of an available therapy that is common and causes discontinuation of a treatment; (3) provides safety and efficacy comparable to those of available therapy but has a benefit that is expected to lead to an improvement in serious outcomes; and (4) has the ability to address emerging or anticipated public health need.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) and is currently being investigated in the Company’s landmark ONWARD
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