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NICE Preliminary Guidance Recommends Trobalt® (retigabine) For Adjunctive Treatment Of Partial Onset Epilepsy

NICE Preliminary Guidance Recommends Trobalt® (retigabine) For Adjunctive Treatment Of Partial Onset Epilepsy

Story from the U.K.

The National Institute for Health and Clinical Excellence (NICE) has issued a Final Appraisal Determination (FAD), recommending retigabine as an option for the adjunctive (add-on) treatment of partial onset seizures with or without secondary generalisation* in adults aged 18 years and older with epilepsy, when previous treatment with other anti-epilepsy drugs (AEDs)** has not provided an adequate response, or has not been tolerated.1 These epilepsy treatments are commonly prescribed as initial monotherapy or used in combination.* **

Epilepsy is a common, chronic disabling neurological condition which affects people of all ages. It is characterised by recurrent epileptic seizures, occurring when there is abnormal and/or excessive neuronal activity in the brain.

Of those people diagnosed with epilepsy in the UK, around 30 percent do not respond to initial epilepsy treatments and remain uncontrolled. This group is considered refractory 2 and equates to approximately 60,000 people in the UK.3-9

Refractory epilepsy has a negative impact on the quality of the lives of patients with the disorder. A 2008 review by Jacoby et al10 concluded that having active epilepsy can profoundly affect the quality of life (QoL) of patients with the condition. Refractory epilepsy is also associated with an increased risk of sudden death and significant costs to society and to the healthcare system.11,12

Retigabine is the first in a new class of epilepsy treatments and is currently the only AED to target neuronal potassium channels13 which are involved in inhibitory mechanisms in the brain, and are thought to have a role in seizure control.14-15

The efficacy and safety of retigabine was established in two pivotal multicentre, randomised, double-blind, placebo-controlled, fixed dose studies .16-17

The NICE recommendation of retigabine will offer patients and clinicians an additional option for difficult to control epilepsy.

“Epilepsy is a highly individual and complex condition which, for a significant percentage of people is difficult to control. Many individuals live with seizures on a regular basis for years despite having had many of the currently available treatments. We have seen that with perseverance, it is possible to improve seizure control and thus the quality of life of people in this group. A drug with a new mode of action, could provide an important new option for people whose lives are blighted by seizures not controlled by their current treatment.” said Dr Ley Sander, Professor of Neurology at UCL Institute of Neurology.

Mark Toms, Medical Director, Neurology, GlaxoSmithKline (GSK) UK commented: “In retigabine we believe we have a new option for people with refractory partial onset epilepsy. This is a patient group, who live with a high level of uncertainty around when and where a seizure might happen. We are delighted that NICE has recognised retigabine as an additional adjunctive treatment option and will continue to actively engage with the NICE process until completion.”

About the NICE Final Appraisal Determination

**The Final Appraisal Determination (FAD) recommends retigabine as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with epilepsy, only when previous treatment with carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate has not provided an adequate response, or has not been tolerated.1

About retigabine

Retigabine is a first-in-class antiepileptic drug acting on the specific Kv7 potassium channels as adjunct treatment for partial-onset epilepsy.13

To date, retigabine has been tested in 1365 patients across all phase I, II and III studies 16-17 Phase III studies for retigabine demonstrated significantly improved seizure control, with a greater number of patients achieving a reduction in the number of seizures by 50% or more, compared with placebo.16-17 Retigabine has an acceptable and manageable side-effect profile.13

Further information can be found in the Summary of Product Characteristics.

About epilepsy

Epilepsy is a neurological condition that affects 456,000 people in the UK18, resulting in brief disturbances in the normal electrical signals of the brain. Partial seizures, which affect part of the brain, are the most common type of seizure experienced by people with epilepsy.

*Partial (or focal) onset seizures originate primarily within (and are usually limited to) one cerebral hemisphere, whereas generalised seizures originate within, and rapidly engage, cerebral hemispheres bilaterally. Partial/focal onset seizures may spread to other areas of the brain and are then referred to as “secondarily generalised”.19

Difficult to control/drug resistant epilepsy refers to people who still experience seizures despite taking medication. Currently 30% of those suffering from epilepsy experience this.2

Most non-elective (emergency) epilepsy hospital admissions are due to seizures.20 In 2007-08, epilepsy was responsible for 51,864 episodes of patient care, accounting for 151,007 occupied bed days.20 In the period of 1993-2000, there were about 800 deaths per year where epilepsy was the underlying cause and about 37,000 admissions where epilepsy was the main diagnosis.21

Via – Medical News Today


1 NICE final appraisal determination of retigabine as an adjunctive treatment for partial onset seizures in epilepsy. June 2011 http://guidance.nice.org.uk/TA/Wave23/33

2 Schiller Y. Seizure relapse and development of drug resistance following long-term seizure remission. Archives of Neurology. Vol.66, No. 10, October 2009

3 Sander, J.W.A.S. (1990) National General Practice Study of Epilepsy: Newly diagnosed epileptic seizures in a general population. Lancet, 336:1267-71

4 Kwan, P. and Brodie, M.J. (2000) Early identification of refractory epilepsy. New England Journal of Medicine, 342:314-319

5 Office of National Statistics (2009). Mid Year Population Estimates 2009: 24/06/10 [online]. Available from: http://www.statistics.gov.uk/statbase/Product.asp?vlnk=15106 [Accessed 01/03/2010]

6 ISD Scotland (2009) Quality & Outcomes Framework (QOF) for April 2008 – March 2009, Scotland. [online] Available from www.isdscotland.org/qof [Accessed 01/03/2011]

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