Sodium oxybate to treat alcohol dependence - 20 years of clinical experience.

Each year, about 20 000 patients are treated with SO and there is an overall good clinical experience. One major concern is that SO is used as a recreational drug and there has been indeed a sharp increase in cases the number of patients in treatment due to GHB addiction and overdosing. Nevertheless, only in approximately 10% of the treated population, craving for or abuse of SO, is observed. Taking all randomized controlled trials (RCTs), clinical controlled trials and controlled prospective studies into consideration, SO appears to be more effective than placebo on alcohol abstinence, controlled drinking and relapses to heavy drinking, and seems to be also more effective than other approved pharmacological interventions. The low number of available studies, the low sample size and the low quality of the included studies limit the validity of these results and suggest the need of conducting new high-quality RCTs with appropriate sample size. A large RCT (SMO.IR trial sponsored by the French Company D&A Pharma) involving almost 500 patients in nine European countries is now on its way to provide data for EMA approval.