June 20 (Reuters) - 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, UCB Pharma's 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 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.