EMA: benefits of sodium oxybate still outweigh risks in alcohol dependence
- CHMP concluded the benefit–risk balance of sodium oxybate 175 mg/ml for acute alcohol withdrawal and long‑term abstinence remains favourable.
- Post‑authorisation studies showed methodological limitations and uncertainties about efficacy, so CHMP recommended new efficacy trials by the marketing‑authorisation holders.
- No new safety concerns about abuse or misuse were identified and existing risk‑minimisation measures were not changed.
- Sodium oxybate 175 mg/ml (Alcover) is authorised in Austria (since 1999) and Italy (since 1991) and will remain available while required studies are completed.
CHMP conclusion
The Committee for Medicinal Products for Human Use concluded that the benefits of sodium oxybate syrup and oral solution (175 mg/ml) continue to outweigh their risks when used to treat acute alcohol withdrawal syndrome and to support long‑term abstinence in people with alcohol dependence.
Efficacy data and required studies
The review, initiated at the request of the French medicines agency under Article 31 of Directive 2001/83/EC, found that post‑authorisation studies had methodological limitations, creating uncertainties about the treatment effect. The CHMP recommended that the companies marketing these medicines conduct new post‑authorisation efficacy studies to better characterise efficacy; if confirmed by the European Commission, completion and submission of the study reports may be imposed as conditions for maintaining the medicines' marketing authorisations.
Safety and risk‑minimisation
The medicines' safety profile remains consistent with existing knowledge. The review did not identify any new safety concerns regarding the risk of abuse or misuse, and the Committee did not request changes to current additional risk‑minimisation measures.
Availability and regulatory next steps
Sodium oxybate 175 mg/ml (Alcover) is authorised nationally in Austria (since 1999) and Italy (since 1991) for alcohol‑related indications and will continue to be available in those countries while the additional studies are carried out. The review did not include the 500 mg/ml sodium oxybate formulation used to treat narcolepsy with cataplexy. The CHMP opinion will be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Source: EMA