A medical study has confirmed that sodium oxybate is effective in the treatment of alcohol dependence.
There are several areas of inquiry into effective treatments (benzodiazepines) available for the treatment of alcohol withdrawal syndrome and there remains an unmet medical need in the abstinence maintenance.
Alcohol dependence currently affects 3.4 percent of the general population aged 18 to 64 in the European Union (EU). The disease is one of the main causes of morbidity (mental health conditions, cardiovascular disease, cancers, and related conditions) and mortality (for example, 49,000 deaths per year attributed to alcohol dependence in France).
In addition, alcohol dependence carries a considerable societal burden. The social cost of alcohol in France is estimated at 120 billion euros per year.
Sodium oxybate has long been considered a key candidate material (especially in Italy and Austria). The chemical exerts a broad mechanism of action on the brain’s reward system. In trials, conducted by Julien Guiraud at the faculty of medicine of the University of Amsterdam, sodium oxybate has shown very positive new results confirming its efficacy in the treatment of alcohol dependence.
The treatment of alcohol dependence in patients targeting abstinence involves two phases:
- A detoxification phase with, if necessary, the treatment of the alcohol withdrawal syndrome, which usually lasts 7 to 10 days.
- An abstinence maintenance phase lasting around 6 months.
The new studies included 1,082 patients and these were conducted by Julien Guiraud together with some leading researchers in the field of addiction treatment: Prof. W. van den Brink (University of Amsterdam Medical School); Prof. A.E. Goudriaan (also of the University of Amsterdam Medical School); and Prof. R. Spanagel University of Heidelberg). Support for the study was provided by D&A Pharma.
The research was based on double-blind randomized trials and meta-analyses of eight studies that investigate the heterogeneity of within- and across-study results. These trials confirmed the efficacy, good tolerance and the safety of sodium oxybate in the maintenance of abstinence, particularly in severe alcohol-dependent patients.
Sodium oxybate has a broad mechanism of action, acting on several neurobiological systems within the brain’s reward system. At therapeutic doses, sodium oxybate mimics the mechanism of action of alcohol, without its toxicity in the body, and without the problem of transfer of dependence.
The new studies can be used to extend the marketing authorization of sodium oxybate to other EU countries, such as France, where alcohol dependence remains a major public health issue.
