New anti-convulsant treatment to reduce serious seizures for idiopathic generalised epilepsy, now available in the UK

Posted in News Review on 14th Jul 2015

First-in-class epilepsy treatment Fycompa® (Perampanel) launches in the UK for Primary Generalised Tonic-Clonic Seizures

Fycompa® (perampanel), a once-daily epilepsy treatment, launched in the United Kingdom on 8th July, for primary generalised tonic-clonic (PGTC) seizures in adults and adolescents (≥12 years) with idiopathic generalised epilepsy (IGE).1

The number of anti-epileptic drugs (AEDs) licensed for the treatment of PGTC seizures is limited2 and as many as 20% of people with idiopathic generalised epilepsy (IGE) remain uncontrolled, despite treatment.3 Perampanel is the first new treatment for PGTC seizures in IGE in five years.4

One third of people in the UK with epilepsy have idiopathic generalised epilepsy. Approximately 60% of these (91,200 people), will experience primary generalised tonic-clonicseizures.5,6,7

Perampanel offers clinicians a first-in-class treatment that reduces PGTC seizures, which are dangerous epileptic events.8 These seizures increase the risk of injury, such as fractured bones, shoulder dislocation and burns.9 Primary generalised tonic-clonic seizures also increase the risk of sudden unexplained death in epilepsy (SUDEP) and are known to lead to atypical absence status epilepticus (ASE),10 seizures that may last for extended time periods. In the UK, SUDEPaccounts for 1,000 deaths each year.11

“The launch of perampanel in the UK for refractory generalised convulsions is welcome news for people living with this type of seizure. Perampanel has a novel mechanism of action and this may explain why some people have such an excellent response in terms of seizure response from these convulsions. Indeed, seizure freedom allows many of these people to lead a more normal life,” comments Professor Ley Sander, Consultant Neurologist at the National Hospital and at the Chalfont Centre for Epilepsy.

PGTC seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax.12 While the seizure generally lasts a few minutes, the person will often feel confused or drowsy for up to a few hours,before returning to normal.8

Perampanel is the first-and-only licensed AED to selectively target the initiation and spread of seizures through inhibition of AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.13 Perampanel is alsoindicated for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.1

One third more patients experienced a reduction in seizure frequency with perampanel over 28 days versus placebo (50% responder rate 64.2% vs 39.5%, respectively; P=0.0019).14 Perampanel demonstrates a reduction in PGTC seizure frequency (per 28 days) versus placebo (76.5% vs 38.4%, respectively; P<0.0001).14 Furthermore, 31% of patients are seizure free during the 13-week maintenance period when treated with perampanel as an adjunctive therapy, compared to 12% in the placebo group.

The most common treatment-emergent adverse events are dizziness, fatigue, headache, somnolence and irritability.14

References

1. Fycompa Summary of Product Characteristics (SPC), Available at: www.medicines.org.uk/emc/medicine/26951
Accessed June 2015

2. Rheims S and Ryvlin P. Exp Opin Pharmacother. 2014;15:1417-1426.

3. Faught E. Rev Neurol Dis 2004;1:S34–S43;

4. Eisai. Data on file. 2015

5. Patient Information. Health. Epilepsy Available at: http://patient.info/health/epilepsy-a-general-introduction (Last accessed: June 2015)

6. Panayiotopoulous CP, The Epilepsies: Siezures, Syndromes and Management. 2015. Bladan Medical Publishing

7. Hauser WA et al. Incidence of Epilepsy and Unprovoked Seizures in Rochester, Minnesota: 1935-1982. 1993. Epilepsia 34(3);453-468

8. Epilepsy Foundation. Types of seizures. Available at: http://www.epilepsy.com/learn/types-seizures. Last AccessedMay 2015

9. Asadi-Pooya AA et al. Seizure 2012;21:165–168.

10. IGE Summary. Epilepsy Foundation http://www.epilepsy.com/information/professionals/about-epilepsy-seizures/idiopathic-generalized-epilepsies
Accessed June 2015

11. Smithson WH et al, Curr Neurol Neurosci Rep 2014 Dec; 14(12):502

12. Epilepsy Action. Generalised seizures. https://www.epilepsy.org.uk/info/seizures/generalised-seizures. Accessed May 2015

13. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011;11:56–63.

14. French J et al. Adjunctive perampanel RCT for PGTC seizures. Association of British Neurologists annual meeting 2015; Abstract #53141

15. Eisai. Data on file. 2015

16. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224 –2233.

ACNR 2015; Online 14/07/15

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