Adial Pharmaceuticals announced the reactivated US Investigational application for their Alcohol Use Disorder therapeutic agent, AD04.
Adial Pharmaceuticals recently announced that the US Food and Drug Administration (FDA) has lifted the clinical hold and reactivated the US Investigational New Drug (IND) application for AD04, Adial’s genetically targeted therapeutic agent for the treatment of alcohol use disorder (AUD).1
According to the National Institute of Alcohol Abuse and Alcoholism (NIAAA) and the Journal of the American Medical Association (JAMA), approximately 35 million people each year struggle with AUD in the United States. The severe health impacts of this data is reflected in the numbers: excessive alcohol use is the fourth leading cause of preventable death, with 31% of driving fatalities resulting from alcohol use and only 7.7% of individuals with AUD receiving treatment.2 These alarming statistics make clear the need for new, innovative therapies for the treatment of AUD.
“Given the prolonged nature of the COVID-19 pandemic, the AUD crisis continues to escalate. For this reason, we have filed for an expedited review of AD04 with the FDA. The acceptance of our manufacturing data, as well as our plan for the proposed clinical study, marks an important milestone as we progress towards evaluating AD04 clinically in the United States. We continue to enroll patients in our landmark ONWARD pivotal Phase 3 clinical trial of AD04 in Europe and look forward to providing further updates as our progress continues,” said William Stilley, Chief Executive Officer of Adial Pharmaceuticals, to press.1
The reactivation of the IND allows for Adial to pursue US expedited review programs for AD04. Additionally, Adial can initiate their planned Phase I pharmacokinetics (PK) clinical study, intended to support a New Drug Application (NDA) submission with the FDA.
1. Adial Pharmaceuticals Announces FDA Reactivation of its Investigational New Drug Application for AD04 in Alcohol Use Disorder. News release. Accesswire. October 21, 2020. https://www.accesswire.com/611528/Adial-Pharmaceuticals-Announces-FDA-Reactivation-of-its-Investigational-New-Drug-Application-for-AD04-in-Alcohol-Use-Disorder
2. Alcohol Addiction. Adial Pharmaceuticals. Accessed October 27, 2020. https://www.adialpharma.com/alcohol-addiction/