EMA starts review of sodium oxybate in alcohol dependence

Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse

European Medical Agency (EMA)’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and to support long‑term abstinence.

The review was triggered by the assessment of a marketing authorisation application in France for a generic medicine containing sodium oxybate. During the assessment, the French medicines agency had concerns about the effectiveness of sodium oxybate in alcohol dependence, based on data from three studies. There were also concerns about the risk of abuse or misuse due to the medicine’s psychoactive properties (effects on the brain), and whether the current measures to minimise these risks are adequate.

Based on these data, EMA will now assess the overall benefit-risk balance of sodium oxybate to treat alcohol withdrawal syndrome and support long-term alcohol abstinence and will review measures to mitigate the risk of abuse or misuse. The Agency will then decide if any regulatory action should be taken.