EMA Reviews Alcohol Dependency Drug After French Concerns
The review comes at the request of the French Medicines Agency and has been initiated under Article 31 of Directive 2001/83/EC. This procedure is used to address concerns over the safety or benefit-risk balance of a medicine or a class of medicines; to resolve disagreements between member states on issues related to the authorization of medicines; or to give an opinion on an issue of Europe-wide interest so that the agency can make a recommendation for a harmonized position across the EU.
The European Commission, any member state, or the company that markets the medicine can initiate a referral. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union. It involves the matter being referred to the Pharmacovigilance Risk Assessment Committee (PRAC) after due notice to the EMA, all member states, and the European Commission.
Narcolepsy Indication
Sodium oxybate (Xyrem) is the sodium salt of gamma-hydroxybutyric acid. As an oral solution (500 mg/mL), it is indicated for the treatment of narcolepsy with cataplexy in adult patients, adolescents, and children from the age of 7 years. The drug is a central nervous system depressant believed to act by attaching to brain cell receptor molecules to promote delta (slow) brain waves and nighttime sleep. When taken at bedtime, Xyrem increases sleep depth and length, reducing the number of sleeping periods during the day and improving symptoms of narcolepsy.
Because of the drug's potential for abuse, it can only be obtained with a special prescription, and treatment should be initiated and maintained under the guidance of a doctor with experience in treating sleep disorders. Doctors are advised to check for a history of or susceptibility to drug abuse before treatment, and to monitor for misuse and abuse during treatment.
Approved for Alcohol Abuse in Austria and Italy
The drug has also been suggested to reduce pain and improve function in fibromyalgia, but the EMA said the data were insufficient to support its use for this in the European population.
However, sodium oxybate is also approved in Italy and in Austria, under the name Alcover, to treat alcohol dependence and alcohol withdrawal syndrome. It is this use that the review will examine. The EMA has confirmed the positive benefit-risk profile of the treatment as prescribed in Italy and Austria. France, however, despite having a high prevalence of alcohol problems, has resisted its use for this purpose.
Trials have suggested that sodium oxybate can rapidly alleviate symptoms of alcohol withdrawal syndrome and was at least as effective as diazepam and clomethiazole. It can also be used in the maintenance of abstinence in alcohol-dependent patients, in whom it is reportedly as effective as naltrexone or disulfiram.
Because existing approved medications are only modestly effective, there is a pressing need for effective treatments with an alternative mode of action, particularly in patients with very high consumption levels. Sodium oxybate also has a favorable safety profile. However, studies in alcohol use disorder have been limited and further investigations have been recommended.
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