An estimated 100 million people suffer from alcohol use disorder (AUD) worldwide, with health authorities citing the condition as one of the leading causes of death among young people. But the market for pharmaceutical treatments targeting AUD has been relatively stagnant, and many current options have significant tolerability issues.
However, after decades of relative stagnation, the drug market in AUD is on the rise. One of the companies hoping to take a slice is Charlottesville, Va.-based Adial Pharmaceuticals. Company expects Phase III data for its pill to treat AUD within next two months, CEO William Stilley says Pharmaceutical technology.
Adial’s pill, called AD04, acts as a serotonin-3 receptor antagonist that may affect neurotransmitters like dopamine and modulate the behavioral effects of alcohol. In a phase IIb trial, a statistically significant difference of 1.71 drinks/day of consumption (p=0.0042) was observed between participants who received AD04 and placebo.
Many treatments currently available have significant drawbacks in terms of tolerance and are not widely used. Vivitrol from Alkermes, the current market leader which is also approved for opioid addiction, is delivered by multiple injections often associated with adverse events. Disulfiram, which first gained FDA approval to treat alcohol abuse in 1949, works by blocking the body’s ability to break down alcohol, causing serious illness and vomiting when drinking. drink consumption.
More than 35 million people in the United States and 55 million people in Europe have an AUD. According to a recent Lancet study, alcohol abuse is the leading cause of death among prime-aged people, defined as ages 15-49.
But despite the prevalence of AUD, which affects approximately 100 million people worldwide, uptake of AUD therapies remains challenging. Many people don’t know they have AUD, and there’s often a stigma associated with pursuing any kind of treatment, Stilley says.
By genetically targeting patients with an oral pill, Adial aims to gain traction in a market that may be on the rise, Stilley says. Depression and erectile dysfunction used to be taboo subjects, but clinical research and new therapeutic developments have made drug discovery a mainstream and effective treatment, he says.
According to GlobalData Consensus Sales Forecast, the global market for AUD indicated drugs is expected to more than double between 2022 and 2027, from $2.25 billion to $4.49 billion.
Next steps for Adial
After releasing its next phase III results, the company plans to seek regulatory advice on whether it can pursue accelerated approval or whether it will need to initiate another trial, Stilley said. The regulatory definition of binge drinking will prove key in the next reading of Adial’s Phase III data. While the previous phase IIb trial measured a reduction in the number of drinks per day and the frequency of days when drinks were consumed, the US FDA requires registration trials to measure a reduction in heavy drinking days. alcohol. As such, the Phase III ONWARD trial uses heavy drinking days as the primary endpoint, with secondary endpoints including total alcohol consumption and incidence of adverse events.
In the ONWARD trial, heavy drinking days are defined as more than 60 g of alcohol per day for men or 40 g of alcohol per day for women. In draft FDA guidelines, the agency describes binge drinking as days with more than four or three standard drinks, for men and women, respectively. “The data [indicate that] almost all of the harm from alcohol abuse stems from this level of heavy drinking,” says Stilley.
If AD04 receives marketing approval, Stilley says its oral formulation could be a key distinguishing factor among existing alternatives. Current treatment options, including disulfiram, are often “extreme” and research has shown that people with AUD would be more receptive to taking an oral pill, he notes. AD04 is designed as a twice-daily pill, but the company plans to study an extended-release formula that would only require one pill a day if AD04 gains marketing approval, Stilley says.