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GSK and Valeant Receive European Authorisation for Trobalt (retigabine)

Tue, 03/29/2011 - 9:37am
Bio-Medicine.Org

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, th

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