Navigation Links
GSK and Valeant Receive European Authorisation for Trobalt (retigabine)

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, the EU prescribing information recommends that an ECG is recorded before the initiation of retigabine in patients who are taking any medication that may interfere with QT intervals or who may have congestive heart failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.(1)

In the pivotal trials, the most frequently reported adverse events with the use of retigabine in combination with other AEDs (occurring in at least 5 percent of subjects and at least twice the placebo rate) were dizziness (23 percent), fatigue (15 percent), confusion (9 percent), vertigo (8 percent), tremor (8 percent), abnormal coordination (7 percent), double vision (7 percent), disturbance in attention (6 percent), memory impairment (6 percent), and visual blurring (5 percent). In addition, somnolence occurred in 22 percent of patients on retigabine compared to 12 percent on placebo.(2-4)  

Retigabine, referred to as ezogabine in the U.S. and Canada, is being jointly developed by GSK and Valeant.

"We are very pleased to have reached such an important milestone in the development of retigabine," said Susan Hall, Ph.D., Head of Research and Development at Valeant.  "There is a significant need for new AEDs and retigabine could potentially play an important role in the management of partial onset seizures in appropriate patients."

This European authorisation represents the first licence for retigabine. Preliminary authorisation was granted by the Swiss Agency for Therapeutics Products in December 2010.  Applications for marketing authorisation have been submitted in six countries in addition to the EU.  In December 2010, GSK and Valeant announced receipt of a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application for ezogabine, the U.S. generic name for retigabine, and are working to submit a response to the FDA as soon as possible in 2011.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit

About Valeant PharmaceuticalsValeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.  More information about Valeant can be found at

About Trobalt™(retigabine/ezogabine)Trobalt™ has been developed by Valeant and GSK as an adjunctive treatment for epilepsy patients aged 18 years and above with partial onset seizures. Retigabine is the non-proprietary name adopted by the International Non-proprietary Name for Pharmaceuticals Substances Program. In the U.S. and Canada, ezogabine is the non-proprietary name adopted by the United States Adopted Name Council. GlaxoSmithKline and Valeant entered into an exclusive worldwide collaboration agreement for Trobalt™ in 2008.

About partial onset seizures in epilepsyEpilepsy is a neurological condition that produces brief disturbances in the normal electrical signals of the brain(5). Partial seizures, which begin in a specific area in one side of the brain, are the most common type of seizure experienced by adults with epilepsy.(6)GlaxoSmithKline Enquiries:UK Media enquiries:

David Mawdsley

(020) 8047 5502Claire Brough

(020) 8047 5502Stephen Rea

(020) 8047 5502Alexandra Harrison

(020) 8047 5502Janet Morgan

(020) 8047 5502David Daley

(020) 8047 5502U.S. Media enquiries:

Nancy Pekarek

(919) 483 2839Mary Anne Rhyne

(919) 483 2839Kevin Colgan

(919) 483 2839Sarah Alspach

(919) 483 2839European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543Gary Davies

(020) 8047 5503Ziba Shamsi

(020) 8047 3289U.S. Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419Jeff McLaughlin

(215) 751 7002Valeant Enquiries:Laurie W. Little

(949) 461 6002Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.Valeant Pharmaceuticals Forward-Looking Statement This press release may contain forward-looking statements, including statements regarding the development or authorisation of retigabine, providing neurologists within Europe with a new therapeutic option for the management of appropriate patients with uncontrolled partial onset seizures, and the potential role of retigabine in the management of epilepsy. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's filings with the SEC and the Canadian Securities Administrators ("CSA"), which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.


  1. Retigabine European SmPC
  2. Brodie, MJ. Efficacy and safety of adjunctive retigabine (ezogabine) in refractory partial epilepsy. Neurology. October 13, Epub ahead of print.
  3. Study report - Retigabine - VRX-RET- E22-301
  4. Porter et al. Randomized, multicenter, dose-ranging trial of retigabine for partial onset seizures. Neurology. 2007;68:1197–1204
  5. Epilepsy Foundation. About Epilepsy & Seizures/FAQ. Available at: [Accessed: 15 March 2011]
  6. Epilepsy Foundation. Types of Seizures. Available at: [Accessed: 15 March 2011]



SOURCE Valeant Pharmaceuticals International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Valeant Pharmaceuticals Extends Contract with J. Michael Pearson as CEO and Appoints Him as Chairman of the Board
2. Valeant Pharmaceuticals Completes Acquisition of PharmaSwiss S.A.
3. Valeant Announces Pricing of Senior Notes
4. Valeant Launches Senior Notes Offering
5. Valeant Pharmaceuticals to Present at RBC Capital Markets 2011 Healthcare Conference
6. Valeant Pharmaceuticals to Announce 2010 Fourth Quarter and Full Year Results on February 24, 2011
7. Valeant Pharmaceuticals Announces License Of ACZONE® (dapsone) Gel 5% In Canada
8. Valeant Launches Senior Notes Offering
9. Valeant Pharmaceuticals to Acquire PharmaSwiss S.A.
10. Regulatory Update - GSK and Valeant Receive Positive Opinion in Europe From the CHMP for Trobalt (Retigabine)
11. Valeant Pharmaceuticals Appoints Philip W. Loberg as Interim CFO
Post Your Comments:
(Date:11/26/2015)... 2015 3D bioprinting market is ... a new report by Grand View Research Inc. Rising prevalence ... demands kidney transplantation is expected to boost the market growth, ... organ transplantation. --> 3D bioprinting market is ... a new report by Grand View Research Inc. Rising prevalence ...
(Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Japanese ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
(Date:11/26/2015)... 2015 ) ... "2016 Future Horizons and Growth Strategies in ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> ) has announced ... Horizons and Growth Strategies in the French ...
Breaking Medicine Technology:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... offering factory direct sauna parts and accessories. , Sauna accessories help improve ... the bather’s style and personality. From basic styles for the purist looking for ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 10, 2015, ... District Court of Connecticut on behalf of a home health care worker who provided ... or former home health care workers employed by Humana, Inc., Humana at Home, Inc., ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... people across the country to celebrate their sobriety and show through pictures what ... “before and after” photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, ...
(Date:11/25/2015)... ... 25, 2015 , ... Wimbledon Health Partners, the industry leader ... Athletics Facebook page to educate the public, parents and school athletic departments ... people under the age of 25 die from sudden cardiac arrest every year. ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for ... aware of the benefits of Botox® in the treatment of moderate facial wrinkling, few ... and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism ...
Breaking Medicine News(10 mins):