Alcover and associated names

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Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC

On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules do not outweigh their risks, and the marketing authorisation cannot be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.

The company requested a re-examination of the initial opinion. After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation cannot be granted.

What is Alcover granules?

Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption. The active substance in Alcover granules, 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, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.

Alcover syrup is available in Austria and Italy.

Why were Alcover granules reviewed?

Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States (the ‘concerned Member States’, in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).

However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.

The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules had not been clearly demonstrated and there are various risks including the risk of dependence, misuse and side effects.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules are insufficient and of inadequate quality to demonstrate that the medicine is effective in the proposed uses. Risk minimisation measures were proposed for the known risks. However, the CHMP concluded that, since the benefits of Alcover granules had not been clearly demonstrated, the marketing authorisation cannot be granted in the reference and concerned Member States.

After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation cannot be granted.

This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.

A European Commission decision on this opinion will be issued in due course.

Name Language First published Last updated
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) (English only) 2017-06-23 2017-10-13

Key facts

Approved nameAlcover and associated names
International non-proprietary name (INN) or common name

sodium oxybate

Associated namesn/a
Class-
Reference numberEMEA/H/A-29(4)/1451
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusOpinion provided by Committee for Medicinal Products for Human Use
Opinion date26/01/2017

All documents

Name Language First published Last updated
Alcover Article-29(4) referral - Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) (English only) 2017-06-23 2017-10-13

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
Opinion provided by Committee for Medicinal Products for Human Use

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