US Prepares Trials of a Drug for Gambling Disorder

^{Infographic on GV104 and its study for gambling disorder}

US-based Hepion Pharmaceuticals is preparing a Phase 2 trial of GV104, an experimental treatment for gambling disorder.

GV104 is a thin film containing nalmefene that is placed inside the cheek. The active ingredient is absorbed through the lining of the mouth, allowing it to partially bypass first-pass metabolism in the liver.

Nalmefene belongs to a class of drugs known as opioid antagonists, which block certain opioid receptors in the brain.

In simple terms, these receptors are involved in the brain’s reward system and can influence pleasure and the urge to repeat certain behaviors.

Researchers therefore believe nalmefene may help reduce gambling cravings and the sense of reward associated with gambling.

Nalmefene itself is not a new substance. It was approved in the United States in 1995 and has been used to reverse the effects of opioid overdose.

There is already some evidence that it may help people with gambling disorder. The American Journal of Psychiatry published the results of a study involving 207 people with the condition.

Among participants who received 25 mg of nalmefene, 59.2% were rated as “much improved” or “very much improved,” compared with 34% in the placebo group.

Reported side effects included nausea, dizziness and insomnia.

The developers now plan to conduct a 12-week Phase 2 trial. This stage is intended to determine whether GV104 can reduce symptoms of gambling disorder and assess how safe the treatment is. The company expects to submit the necessary regulatory paperwork in 2027.

There is currently no medication approved specifically for gambling disorder. Treatment is mainly based on psychotherapy, support groups and other psychological interventions.

According to the National Council on Problem Gambling, around 2 million US adults meet the criteria for severe gambling problems, while nearly 20 million report at least one recurring problematic gambling behavior.

If GV104 proves effective, it could be used alongside psychotherapy rather than as a replacement for it.