The European Medicines Agency (EMA) has been asked to review its decision to refuse marketing authorisation for Hopveus (sodium oxybate) for the treatment of alcohol dependence (alcohol withdrawal syndrome and maintenance of abstinence) in adults in whom other treatments are not effective or cannot be used.
Hopveus is a new development of Alcover (sodium oxybate). Alcover solution is authorised in Italy and Austria through national procedures.
The EMA considered that the supporting data from three clinical studies – two comparing Hopveus to placebo (n=810) for alcohol dependence and one comparing Hopveus with oxazepam (n=126) for alcohol withdrawal syndrome – did not conclusively demonstrate efficacy. The agency was also concerned about several drawbacks in the design and analysis of these studies. There was also concern regarding the potential misuse and abuse of the medicine. Under the circumstances, the Agency’s opinion, issued on October 17, was that the benefits of Hopveus did not outweigh its risks and it recommended against marketing authorisation.
The applicant for Hopveus has now requested a re-examination of the EMA’s initial opinion. The agency says that, upon receipt of the grounds for the request, it will re-examine its opinion and issue a final recommendation.