MediciNova announces publication of positive findings on MN-166 (ibudilast) in alcohol dependence.
MediciNova, Inc. announced that the medical journal Neuropsychopharmacology has published a new article on MN-166 (ibudilast) written by Dr. Lara Ray and colleagues at the University of California, Los Angeles. The article reports that MN-166 (ibudilast) was associated with mood improvements on the stress- and alcohol-cue exposures, as well as reductions in overall craving, depression and anxiety for alcohol in subjects diagnosed with alcohol use disorder (AUD). Moreover, in the subjects that had higher depressive symptomatology, MN-166 (ibudilast) reduced the stimulant and mood-altering effects of alcohol compared to placebo.
Major findings from the publication, “Development of the Neuroimmune Modulator Ibudilast for the Treatment of Alcoholism: A Randomized, Placebo-Controlled, Human Laboratory Trial,” include the following:
In an intravenous alcohol challenge session in subjects reporting higher levels of depressive symptomatology as measured by the Beck Depressive Inventory (BDI) Scale:
- ibudilast significantly decreased the alcohol-induced stimulation (p < 0.05),
- ibudilast significantly decreased alcohol-induced positive mood (p < 0.05),
- ibudilast significantly decreased ‘wanting’ of alcohol (p < 0.05), and
- ibudilast showed a trend to decreased ‘liking’ of alcohol (p = 0.06).
While ibudilast decreased the alcohol-induced rewarding effects described above during the alcohol challenge, it also increased negative mood responses to alcohol (p < 0.05) in subjects reporting higher levels of depressive symptomatology on the BDI.
Overall, MN-166 (ibudilast) was well tolerated. There were no severe adverse events and there were no study dropouts directly related to MN-166 (ibudilast).
About the Clinical Trial
This randomized, double-blind, placebo-controlled study enrolled 24 non-treatment seeking individuals with either alcohol abuse or dependence in a UCLA research unit. Participants were randomly assigned to a 7-day treatment period involving repeat oral administration of either MN-166 (ibudilast) escalated up to 100 mg/day or placebo. During the treatment period, participants were administered the study medication, completed an IV alcohol challenge, and took part in laboratory tests of alcohol craving as well as mood assessments and standard safety tests. Following a 7-10 day study break, trial participants re-enrolled for another 7-day period wherein they crossed over to the other treatment condition. The key study outcomes included safety, tolerability and preliminary efficacy as indicated by whether MN-166 (ibudilast) reduced alcohol craving and the rewarding effects of alcohol under controlled experimental conditions of cue exposure and alcohol administration.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS and drug use disorders. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease), substance abuse/addiction and chronic neuropathic pain.
(Source: Globe Newswire)
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Filed Under: Drug Discovery
