LONDON and MISSISSAUGA, Ontario, March 29, 2011 /PRNewswire/ —
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International,
Inc. (NYSE:
VRX) (TSX: VRX) announced today that the European Commission
has granted marketing authorisation for Trobalt™ (retigabine)
as an adjunctive (add-on) treatment of partial onset seizures (a
form of epilepsy where a seizure begins in a specific area in one
side of the brain), with or without secondary generalisation in
adults aged 18 years and above with epilepsy.(1)
“The European authorisation of retigabine is very welcome as it
will provide neurologists within Europe with a new therapeutic
option for the management of appropriate patients with uncontrolled
partial onset seizures,” said Dr. Tony Hoos, Senior Vice President,
European Medical Affairs, GSK.
This European licence was supported by the results of the
pivotal phase III studies RESTORE 1 and 2, and Study 205, a phase
IIb study. The results of these three studies showed that more
patients with partial onset seizures saw a reduction of 50% or more
in seizure frequency compared to placebo, when a 600mg, 900mg or
1200mg dose of retigabine was added to their current anti-epileptic
drug (AED) therapy.(1)
In controlled clinical studies with retigabine, urinary
retention occurred at a rate of 0.9 percent in patients receiving
the drug compared to 0.5 percent on placebo. Across the phase
II/III safety population there were four (0.3%) serious adverse
events of urinary retention, three of which were known to have
resulted in withdrawal. The EU prescribing information therefore
recommends that retigabine is used with caution in patients at risk
of urinary retention.(1)
Retigabine also caused a prolongation of the QT interval
(electrical activity of the heart) when used at the highest dose in
healthy volunteers in a thorough QT study. As a precaution,
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