Adial Pharmaceuticals, Inc. has filed a Fast Track application with the US Food and Drug Administration (FDA) for its lead drug candidate, AD04. The drug is meant to target people with specific genes for whom other alcohol addiction therapies have failed. To take the drugs, a person must be diagnosed with alcohol use disorder.
Why Fast-Track AD04?
Several medication-assisted treatment options exist for alcoholics, but they are not considered to fail-proof or even useful for most people. They also carry a level of stigma that prevents doctors from prescribing them.
In America, treatment for alcohol use disorder often focuses on total abstinence, which many people with alcohol use disorder reject or, for whatever reason, are unable to achieve. While several drugs, including Topomax, have shown to be effective at preventing compulsive drinking, few treatment centers feel comfortable recommending a drug that allows people to continue drinking. (Other drugs make people incredibly ill if they drink while taking them.)
Adial requested AD04, a therapeutic agent for treating alcohol use disorder (AUD) in patients with target genotypes. Because this drug targets a person’s genetic makeup, it is considered likely safer than chemicals.
Who Will It Work For?
Genetic researchers believe that for some people, a genetic flaw may be the secret to compulsive drinking. Adial says that AD04 “had a significant effect in patients with AUD who did not tolerate available therapy or failed to respond to said therapy.” People who tried to quit cold-turkey or through alcohol treatment centers may benefit from the drug.
AD04 also has a safety profile that is better or as good as other available alcohol treatments. When compared, it had less chance of toxicity.
Adial says that while medication-assisted treatment is already underused, AD04 adds a valuable tool to the arsenal for treatment centers when they begin to accept that there are benefits to MAT for people with alcohol use disorders.