French company D&A Pharma calls France to use of sodium oxybate to help alcohol-dependent people maintaining abstinence although the European Medicines Agency has a different opinion.
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"There is a drug whose efficacy has recently been reaffirmed, and which has been prescribed in Italy and Austria for over 30 years to 300,000 patients. Its name is Alcover", the company says.
"Its active ingredient, sodium oxybate, was discovered by French professor Henri Laborit, and is used to help alcohol-dependent people maintaining abstinence. A university thesis on the subject has just been published by the Faculty of Medicine at the University of Amsterdam.
"Validated by some of Europe's leading specialists in alcohol dependence, and meeting the most recent methodological and regulatory standards, its results confirm the efficacy, tolerability and safety of sodium oxybate in maintaining abstinence, particularly in severely dependent patients.
"They also further strengthen the efficacy and safety data on the basis of which the European Medicines Agency was able to confirm in 2018 the positive benefit-risk profile of the treatment as prescribed in Italy and Austria.
"Behind these scientific advances, the hope that this treatment will soon be authorized in France", the company says.
"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 were not clearly demonstrated and there were various risks including the risk of dependence, misuse and side effects.
"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 were insufficient and of inadequate quality to demonstrate that the medicine would be 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 were not clearly demonstrated, the marketing authorisation could not be granted in the reference and concerned Member States.
"After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017." ■