Hitting the Fast Track: Alcohol Use Disorder Treatment Filing with FDA

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Adial Pharmaceuticals, Inc. is filing an application for Fast Track with the US Food and Drug Administration (FDA) for its lead drug candidate, AD04.

Adial previously requested AD04, a therapeutic agent for the treatment of alcohol use disorder (AUD) in patients with target genotypes, be considered for the FDA expedited review program.

“We are working with our regulatory counsel to prepare our Fast Track submission after consultation with the FDA,” Adial’s CEO, William Stilley, said to the press “Following our submission, the FDA is expected to review the request and make a decision within 60 days.”¹

When a Fast Track application is reviewed, the submitted drug must demonstrate advantages over the currently available and approved therapy, thus meeting an unmet medical need. Advantages Adial believes AD04’s advantages include the following: 1) AD04 had a significant effect in patients with AUD who did not tolerate available therapy or failed to respond to said therapy; 2) AD04 saw a decrease in clinically significant toxicity of a common available therapy that often causes discontinuation of treatment; 3) AD04 has a safety and efficacy profile similar to that of available therapies, but is expected to enhance improvement in serious cases of AUD; 4) AD04 addresses the anticipated public health need.

“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,” Adial’s Head of Regulatory, Jack Reich, PhD, commented to press. “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.”¹

Cornel N. Stanciu, MD, MRO, had this to say: "You can look at the issue of pharmacotherapy for alcohol use disorders in two ways. On one hand, currently only 6% of those with an alcohol use disorder receive any of the FDA approved medications for relapse prevention, so we are not making use of what is available. On the other hand, addictionologists like myself need more tools to be able to tailor and personalize treatments for individual sufferers as one size does not fit all. This development presents a step forward towards a novel type of drug development to address an unmet medical need."

Reference

1. Adial Pharmaceuticals. Adial to file Fast Track application for AD04 with the FDA. News release. February 23, 2021. https://ir.adialpharma.com/press-releases/detail/112/adial-to-file-fast-track-application-for-ad04-with-the-fda