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Alcohol use disorder (AUD) is a mental disorder with multiple pathogenic chronic diseases associated with a variety of physical and mental sequelae.
tolerance, withdrawal, impaired control of drinking behavior, and persistent drinking regardless of adverse consequences are some of the most common characteristics of alcohol dependence.
Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has restarted its review of AD04's application for new research drugs (INDs) and allowed clinical trials of AD04.
AD04 is a gene-targeted treatment for alcohol use disorders (AUD).
the company will focus on ONWARD's Phase III clinical trials in Europe, submitting manufacturing data to the European Medicines Agency (EMA) before starting the ONWARD test, but this data has not yet been submitted to the FDA because the trial has not yet been conducted in the United States.
relaunching Adial's IND will allow the company to pursue AD04's rapid review in the U.S. and launch Phase I Pharmacodynamics (PK) clinical studies in the U.S.
, chief executive of Adial Pharmaceuticals, said: "Given the long-term nature of the COVID-19 pandemic, the crisis of alcohol use disorder (AUD) will continue to escalate.
, we have applied to the FDA for a quick review of AD04."
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