D&A Pharma: New confirmation for sodium oxybate in the treatment of alcohol dependence
While several effective treatments (benzodiazepines) are currently available for the treatment of alcohol withdrawal syndrome, there is an unmet medical need in the abstinence maintenance phase. With its broad mechanism of action on the brain's reward system, sodium oxybate has shown very positive new results confirming its efficacy in the treatment of alcohol dependence and which are presented in the PhD thesis of Julien Guiraud that was carried out at the faculty of medicine of the University of Amsterdam.
These new studies included 1,082 patients and were conducted by Julien Guiraud and a group of international experts under the supervision of renowned professors in the field of addiction treatment:
- Prof. W. van den Brink: Professor of Psychiatry and Addictology at the University of Amsterdam Medical School (Netherlands)
- Prof. A.E. Goudriaan: Professor of Addictology, specialist in the neurobiology of addiction, University of Amsterdam Medical School (Netherlands)
- Prof. R. Spanagel: Professor, Scientific Director of the Institute of Psychopharmacology, Central Institute of Mental Health.
Mannheim Medical School, University of Heidelberg (Germany)
The thesis is based on double-blind randomized trials and meta-analyses of eight studies that investigate the heterogeneity of within- and across-study results. These trials and meta-analyses confirm the efficacy, the 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.
Alcohol dependence currently affects 3.4% of the general population aged 18 to 64 in the European Union (EU). It is one of the main causes of morbidity (mental health conditions, cardiovascular disease, cancers, etc.) and mortality (49,000 deaths per year attributed to alcohol dependence in France)1. In addition, the social cost of alcohol in France is estimated at 120 billion euros per year2.
For 30 years, Italy and Austria have been successfully using sodium oxybate to help many patients overcome alcohol dependence. Given the urgency of the ever-growing medical need, these 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.
1. Source : Santé publique France
2. Source : OFDT