Adial to File Fast Track Application for AD04 with the FDA

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.