News
Adial Pharma to file at FDA for Fast Track review for AD 04 a treatment of alcohol use disorder.
Adial Pharmaceuticals, Inc.announced that it will be filing an application for “Fast Track” with the FDA for its lead drug candidate, AD 04, 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 AD 04 should be considered eligible for an FDA expedited review program. Adial and its regulatory advisors had previously concluded that AD 04, which is being developed for a serious condition that is an unmet medical need, is a candidate for this FDA program.
Condition: Alcohol Dependence
Type: drug
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins