As COVID vaccines spread globally, many are returning to pre-pandemic life with routine and socialization. But what about the other pandemics? The problems of mental health and drug addiction have been prevalent in our society long before the coronavirus but were gravely exacerbated over the past year to the point that they might be called a “second pandemic.”

The economic struggle combined with losing loved ones, healthcare, career opportunities, shelter, other disruptions to quality of life have caused some to turn to drugs and alcohol for comfort or an escape. Those who were previously addicts are no doubt struggling, but more and more names get added to the list daily.

It’s been predicted that alcohol use increased globally by 75% over the past 12 months. So how does our society tackle this pandemic of Addiction? Adial Pharmaceuticals has one strategy.

An Older Pandemic

Alcohol use disorder (AUD) is known as the No. 1 cause of death to people considered to be in their prime. Aside from the many personal burdens that AUD puts on individuals and their families, the economic and global burdens are just as heavy.

According to the American Journal of Preventive Medicine, in 2010, alcohol misuse cost the United States $249 billion — 77% of which is due to heavy and binge drinking days. And the World Health Organization reported in 2016 that 3 million deaths or 5.3% of all global deaths (7.7% for men and 2.6% for women) were attributable to alcohol consumption — 13.5% of all deaths for ages 20-39.

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the treatment and prevention of addictions, is currently in Phase 3 testing of its lead investigational drug product called AD04. The company developed AD04 as a genetically-targeted therapeutic agent for the treatment of AUD.

Phase 2b Results

A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing the frequency and quantity of drinking and heavy drinking with no overt safety concerns.

During the trial, ondansetron, the active pharmaceutical agent in AD04, showed a statistically significant difference in contrast with the placebo for both the primary endpoint and secondary endpoint, which were the reduction in the severity of drinking measured in drinks per day and the reduction in the frequency of drinking measured in days of abstinence/no drinking.

Additionally, and importantly, the Phase 2b results showed a significant decrease in the percentage of heavy drinking days. “Heavy drinking days” were defined as any day with four or more alcoholic drinks for women or five or more alcoholic drinks for men consumed within the same day and are well-documented as the days that cause damage due to alcohol.

How AD04 Would Work

Unlike other therapies, Adial’s investigational product, AD04, involves genetic screening with a companion diagnostic genetic test prior to treatment and uses a novel mode of action that is designed to reduce cravings for alcohol to effectively curb alcohol intake, without the requirement of abstinence prior to or during treatment. It is expected to help people reduce their drinking or maintain abstinence. AD04 is intended to be easy to use; administered orally on a twice-daily basis, with a once-a-day tablet planned for the future.

Adial’s strategy is to integrate pretreatment genetic screening with a test distributed to prescribers into AD04’s label to create a patient-specific treatment in one integrated therapeutic offering. The company’s goal is to develop a genetically targeted, effective and safe product candidate to treat AUD to help people live healthier and more fulfilling lives. According to the FDA, Adial’s AD04 is the only drug addressing AUD in this breakthrough method that has reached Phase 3 testing.

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