The European Medicines Agency (EMA) has initiated a comprehensive review of medicines containing sodium oxybate used in alcohol dependence treatment, following concerns about the drug's effectiveness and potential for abuse raised by French regulatory authorities.
The review was triggered during the assessment of a marketing authorization application in France for a generic sodium oxybate medicine. The French medicines agency identified concerns about the drug's effectiveness in alcohol dependence based on data from three studies, as well as worries about abuse and misuse risks due to the medicine's psychoactive properties.
Mechanism and Current Applications
Sodium oxybate functions by attaching to gamma-aminobutyric acid (GABA) receptors on nerve cells in the brain and spinal cord, leading to a calming effect on cellular activity. Since it targets these receptors in the same way as alcohol, sodium oxybate is used to treat alcohol withdrawal symptoms in alcohol-dependent patients, including agitation, tremor, and sleep problems, while supporting abstinence efforts.
Currently, sodium oxybate 175 mg/ml is authorized nationally in Austria and Italy under the brand name Alcover. In Austria, it is available as a syrup for treating alcohol withdrawal syndrome and supporting long-term abstinence under medical supervision alongside psychotherapy and social rehabilitation. In Italy, it is available as an oral solution used as an adjuvant medicine to control acute alcohol withdrawal syndrome.
Regulatory Review Process
The EMA's Committee for Medicinal Products for Human Use (CHMP) will conduct the review, assessing the overall benefit-risk balance of sodium oxybate for treating alcohol withdrawal syndrome and supporting long-term alcohol abstinence. The committee will also review current measures designed to mitigate the risk of abuse or misuse.
The review was initiated under Article 31 of Directive 2001/83/EC at the request of the French medicines agency. Following the CHMP's assessment, the committee will adopt an opinion that will be forwarded to the European Commission, which will issue a final legally binding decision applicable across all EU Member States.
Scope and Implications
The review specifically focuses on sodium oxybate medicines used in alcohol dependence management and does not include sodium oxybate oral solution (500 mg/ml) used to treat narcolepsy. The regulatory action will determine whether any changes are needed to the current authorization status or risk management measures for these alcohol dependence treatments.
The outcome of this review could significantly impact treatment options for alcohol-dependent patients across the European Union, particularly regarding the availability and prescribing conditions for sodium oxybate-based therapies in this indication.
