FDA Denies Adial Pharma's Fast Track Request For AD04 in Alcohol Use Disorder

Adial Pharmaceuticals Inc ADIL has received notice from the FDA that its request for Fast Track Designation for AD04 in Alcohol Use Disorder has been denied at this time.
The FDA stated that the Company has not yet demonstrated that the product shows potential, and the agency asked for additional information regarding how AD04 might compare to other therapies.
Based on this feedback, Adial will review the additional requirements and data requested by the FDA for a Fast Track Designation.
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.
AD04 is undergoing a Phase 3 ONWARD trial. The primary endpoint of efficacy is the change from baseline in the monthly number of heavy drinking days during the last eight weeks of the 24-week treatment period.
Price Action: ADIL shares are up 3.17% at $2.60 during the premarket session on the last check Friday.