GREAT INTEREST IN THE PHASE 2 TRIAL FOR PATIENTS WITH AUD

At the 36th ECNP Congress in Barcelona Spain October 6-10, 2023, Professor Bo Söderpalm, Addiction Biology Unit, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden, presented the promising results from the Phase 2 trial in Sweden with patients suffering from Alcohol Use Disorder (AUD). The results aroused great interest among the congress participants. The study, announced this spring, has evaluated the efficacy, safety, and tolerability of the combination of varenicline and bupropion vs. placebo for patients with moderate to severe AUD.

Alcohol Use Disorder (AUD) is number four on the Global Burden of Disease list, afflicting 100 million people, causing 3 million deaths/year, and generating enormous costs. The dopamine deficiency hypothesis of AUD posits that ethanol intake is driven by negative reinforcement generated by a low dopamine state in the brain.

An investigator initiated thirteen-week randomized placebo-controlled trial (n=388) was conducted at four clinical research sites in Sweden, exploring if co-administration of two drugs with supplementary dopamine enhancing actions, varenicline and bupropion reduces alcohol intake in patients with moderate to severe AUD.

The results of the study give strong value proposition for patients and prescribers:

• Proven efficacy in reducing alcohol consumption in patients with moderate to severe AUD in regulatory accepted endpoints (proportion of Heavy Drinking Days (HDD) and Total Alcohol Consumption (g)
• Significant and clinically relevant reduction in alcohol consumption; in proportion of Heavy Drinking Days vs placebo with 12% and in proportion of Heavy Drinking Days from baseline with 43%
• The combination of varenicline+bupropion significantly reduced the co-primary outcomes compared to placebo; phosphatidylethanol in blood (B-PEth) p<0.004 and self-reported heavy drinking days (%HDD) p<0.008 (ITT analysis)
• The effect of the combination treatment was enhanced in the Per Protocol population
• Secondary outcomes: the combination shows positive results across the majority of efficacy endpoints

The results support the dopamine deficiency hypothesis of AUD and suggest that varenicline+bupropion may considerably reduce alcohol intake and thereby the risk to die from alcohol-related causes.

“We are hopeful that the development of a new pharmaceutical treatment option will have the potential to making everyday life better for the many individuals around the world suffering from AUD”, Professor Bo Söderpalm said.

Reference: Abstract from European College of Neuropsychopharmacology, 6-10 October, 2023.