EU reviews risk of abuse in some treatments for alcohol dependency
Bengaluru: The
European Medicines Agency
has begun a review of medicines to treat alcohol dependency that contain
sodium oxybate
, it said on Friday, following concerns of potential misuse or abuse.
The regulator's review comes after the French medicines agency raised questions about the effectiveness of a generic drug with sodium oxybate to treat the condition, based on three studies, and warned of a possible risk of abuse due to its effects on the brain.
The active ingredient attaches itself to receptors for the neurotransmitter GABA in the brain and the spinal cord, calming their activity.
Sodium oxybate is sold as a syrup in Austria and as an oral solution in Italy for alcohol dependency under the name Alcover by privately owned D&A Pharma.
In Europe, Jazz Pharmaceuticals' drug containing sodium oxybate, Xyrem, is approved to treat narcolepsy - a neurological disorder characterized by excessive daytime sleepiness and sudden muscle weakness.
D&A Pharma and Jazz did not immediately respond to Reuters request for comment.
Alcover is used to treat symptoms of alcohol withdrawal such as agitation, shaking and problems sleeping, either alone or as an add-on treatment. It is also used to support long-term abstinence from alcohol, along with counseling and social rehabilitation.
The EMA's human medicines committee will assess the benefit-risk balance and evaluate measures to prevent misuse.
Sodium oxybate is a form of GHB, or gamma hydroxybutyrate, which is a colorless and tasteless liquid. U.S. regulators have previously raised concerns about misuse of GHB as a party or "date-rape" drug due to its strong sedative effects.
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EU reviews risk of abuse in some treatments for alcohol dependency
Bengaluru: The European Medicines Agency has begun a review of medicines to treat alcohol dependency that contain sodium oxybate , it said on Friday, following concerns of potential misuse or abuse. The regulator's review comes after the French medicines agency raised questions about the effectiveness of a generic drug with sodium oxybate to treat the condition, based on three studies, and warned of a possible risk of abuse due to its effects on the brain. The active ingredient attaches itself to receptors for the neurotransmitter GABA in the brain and the spinal cord, calming their activity. Sodium oxybate is sold as a syrup in Austria and as an oral solution in Italy for alcohol dependency under the name Alcover by privately owned D&A Pharma. In Europe, Jazz Pharmaceuticals' drug containing sodium oxybate, Xyrem, is approved to treat narcolepsy - a neurological disorder characterized by excessive daytime sleepiness and sudden muscle weakness. D&A Pharma and Jazz did not immediately respond to Reuters request for comment. Alcover is used to treat symptoms of alcohol withdrawal such as agitation, shaking and problems sleeping, either alone or as an add-on treatment. It is also used to support long-term abstinence from alcohol, along with counseling and social rehabilitation. The EMA's human medicines committee will assess the benefit-risk balance and evaluate measures to prevent misuse. Sodium oxybate is a form of GHB, or gamma hydroxybutyrate, which is a colorless and tasteless liquid. U.S. regulators have previously raised concerns about misuse of GHB as a party or "date-rape" drug due to its strong sedative effects.
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