Hopveus

Hopveus was developed as a medicine for treating alcohol dependence (alcohol withdrawal syndrome and maintenance of abstinence) in adults. During the evaluation, the company changed the proposed indication to substitution treatment for alcohol dependence in patients in whom other treatments are not effective or cannot be used. During the re-examination, the company further changed the intended indication to treatment of alcohol withdrawal syndrome and maintenance of abstinence under careful medical supervision along with psychotherapy and social rehabilitation.

Hopveus contains the active substance sodium oxybate and was to be available as granules in sachets to be taken by mouth.

The active substance in Hopveus, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gamma-aminobutyric acid (GABA), leading to a calming of the activity of these cells. Since it targets these receptors in the same way as alcohol, Hopveus granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and sleeping problems, and to support continued abstinence.

The company presented the results of three main studies: two compared sodium oxybate with placebo (a dummy treatment) in 810 patients with alcohol dependence and one study compared sodium oxybate with oxazepam in 126 patients with alcohol withdrawal syndrome.

Although some of the studies presented suggested that the medicine could be effective, this was not conclusively demonstrated, and the Agency had concerns about several drawbacks in the design and analysis of these studies that could have affected the results.

As the data were insufficient to establish the effectiveness of Hopveus, the Agency’s opinion was that the benefits of Hopveus did not outweigh its risks and it recommended refusing marketing authorisation.

The Agency’s concerns on Hopveus’ effectiveness could not be addressed by further restricting the use of Hopveus as the company proposed. The refusal was therefore confirmed after re-examination.

The company informed the Agency that there is no impact on patients in clinical trials with Hopveus.

If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.