Investigational Alcohol Use Disorder Drug Shows Efficacy in Clinical Trials

MediciNova recently announced positive findings from an investigational drug, ibudilast (MN-166), for the treatment of alcohol use disorder.

In a study published by Neuropsychopharmacology, the researchers discovered that ibudilast was able to improve mood on stress- and alcohol-cue exposures. The drug was also observed to reduce cravings, depression, and anxiety in patients diagnosed with alcohol use disorder.

Included in the study were 24 patients with alcohol use disorder who were randomized to receive a 7-day treatment of ibudilast or placebo. The participants were administered the treatment, and then underwent an intravenous alcohol challenge. Then, they underwent a series of tests to determine cravings, mood, and safety of the drug.

Primary and secondary outcomes of the trial included safety, tolerability, and efficacy indicated by whether the drug reduced cravings, and the rewarding effects of alcohol in a controlled environment, according to the study.

The researchers reported that ibudilast showed the ability to reduce the altering effects of alcohol in patients with higher depressive symptoms, compared with placebo.

Through intravenous alcohol challenge sessions, patients with high levels of depressive symptoms reported significantly decreased stimulation from alcohol. These patients also experienced a significantly decreased positive mood resulting from alcohol consumption, according to the study.

Patients treated with ibudilast were also shown to have a decreased wanting and liking of alcohol. While treatment with ibudliast decreased the rewarding effects of alcohol, it increased negative mood responses to alcohol use.

Overall, the authors found that the typical symptoms of alcohol use disorder were not observed in patients taking ibudilast.

The investigators found that ibudilast was generally well-tolerated with no serious adverse events reported, according to the study. No patients discontinued treatment due to adverse events.

These findings suggest that the drug is an effective treatment for patients with alcohol use disorder who currently only have buprenorphine as an option for drug therapy.

Ibudilast is a small molecule phosphodiesterase-4 and -10 inhibitor, and a macrophage migration inhibitory factor inhibitor, which is able to stop inflammatory cytokines. It also reduces the effects of glia cells that are implicated in multiple neurologic conditions.

The drug has been explored in multiple preclinical and clinical trials, which have demonstrated its efficacy in treating neurodegenerative conditions, substance use disorders, and chronic neuropathic pain, according to the study.

Since 1989, ibudilast has been used in Japan and Korea to treat patients with asthma and those who have experienced a stroke. MediciNova is now developing the drug to treat multiple sclerosis, ALS, and other substance use disorders, the company reported.