THE RESULT FROM THE AUD PHASE 2 TRIAL PUBLISHED IN THE LANCET REGIONAL HEALTH – EUROPE
The result of the phase 2 trial for patients with Alcohol Use Disorder (AUD) study has been published in The Lancet Regional Health – Europe. The result shows that two existing medications with complementary effect on dopamine – varenicline and bupropion – reduce alcohol cravings, lowers consumption, and may decrease the risk of nausea.
The result of the study introduces a new treatment strategy: boosting dopamine levels in the brain. The researchers have based their approach on the hypothesis that dopamine deficiency drives the craving for alcohol. To enhance dopamine signaling they combined varenicline, which stimulates dopamine release via nicotine receptors, with bupropion, which helps the brain maintain dopamine levels after release.
Sobrera Pharma´s CEO Ann-Charlotte Rosendahl says the result is very promising:
“AUD is a common chronic disorder that is estimated to account for about five percent of the global disease burden and shorten the lives of those with severe forms of the disorder by 25 years or more. Despite the high occurrence, significant unmet medical needs exist in the management of AUD. Our expectation is that the development of a new pharmaceutical treatment strategy has the potential to make everyday life better for all those suffering directly and indirectly from AUD”, says CEO Ann-Charlotte Rosendahl.
A total of 384 individuals with moderate to severe alcohol use disorder took part in the 13-week study at four alcohol clinical research sites in Sweden. Participants were randomly assigned to one of four groups, receiving either the combination treatment, one of the two drugs alone, or a placebo. Neither the participants nor the researchers knew who received what during the trial.
The result shows that the greatest reduction in alcohol consumption accurs among those who received the combination therapy. Varenicline alone also produced a measurable effect. The outcome was assessed using both blood biomarkers (B-PEth, which indicates whether a person has consumed alcohol regularly over the past few weeks) and self-reporting.
The clinical trial has been led by Bo Söderpalm, professor of psychiatry at the Sahlgrenska Academy, University of Gothenburg, and senior physician at Sahlgrenska University Hospital, together with Andrea de Bejczy, PhD researcher affiliated with the Sahlgrenska Academy and resident physician at Sahlgrenska University Hospital, Sweden.
“We observed a higher effect compared to currently available medications, which is highly promising. However, additional studies are required before the combination treatment can be approved for alcohol use disorder”, says Professor Bo Söderpalm.
“Nausea is a well-known and troublesome side effect of treatment with varenicline. It was surprising but very encouraging to see that nausea decreased when bupropion was added. The fact that the combination treatment is more tolerable for patients increases the chances that they will complete the full course of treatment”, says Andrea de Bejczy, affiliated with research.
Link below to the publication in The Lancet Regional Health – Europe .