New Medicines Profile

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1 New Medicines Profile February 2010 Issue No. 10/02 Eslicarbazepine Concise evaluated information to support the managed entry of new medicines in the NHS Brand Name, (Manufacturer): Zebinix (Eisai Limited) BNF Therapeutic Class: Licensed Indications: Adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. Dosage and Administration: Starting dose 400mg once daily increased to 800mg once daily after one or two weeks. Based on individual response, the dose may be increased to 1,200mg once daily. Presentation: 800mg tablets. Pack of 30, Marketed: October 2009 Cost Comparisons: Cost for 28 days treatment (prices taken from Mims December 2009) Carbamazepine 400mg bd Oxcarbazepine 450mg bd Lamotrigine 150mg bd Eslicarbazepine 800mg od Summary Eslicarbazepine acetate is a new antiepileptic drug (AED) which is licensed as add-on therapy in adults with partial-onset seizures with or without secondary generalisation. In three 12-week clinical trials eslicarbazepine has been shown to be more effective than placebo at a dose of 800mg or 1,200mg once daily as add-on treatment in patients receiving one or more AEDs in the management of simple and complex partial seizures with or without secondary generalisation. There are no active-comparator trials. Data from open-label extension studies of one year duration suggest that the efficacy of eslicarbazepine is maintained. Eslicarbazepine has similar adverse effects to oxcarbazepine. The most common adverse effects are dizziness, somnolence, headache, diplopia, nausea and abnormal coordination. These are more frequent in patients treated concurrently with carbamazepine. Data on eslicarbazepine are limited. Further trials are needed to ascertain if it offers advantages over other AEDs in terms of efficacy, safety and quality of life. For patients who have not responded well to other treatments it may be an alternative although it is not clear which patients would benefit most. Currently there are no published economic analyses however, compared with alternative AEDs eslicarbazepine is expensive NB. Prices shown are for general comparison and do not imply therapeutic equivalence. Introduction Eslicarbazepine acetate (Zebinix ) is a new antiepileptic drug (AED) licensed as add-on therapy in adults with partialonset seizures with or without secondary generalisation. 1 It is a prodrug of eslicarbazepine, the active component, which acts by blocking voltage-gated sodium channels. It is chemically related to carbamazepine and oxcarbazepine. 2 NICE guidance on newer AEDs (2004) recommends monotherapy with an older drug e.g. carbamazepine or sodium valproate, as initial first-line treatment for epilepsy. 3 If monotherapy does not result in seizure freedom then combination therapy may be needed. Treatment is often limited by adverse effects and drug interactions. Despite the availability of a range of AEDs only 52% of patients with epilepsy achieve seizure-free status (2004 data). 4 Evidence Data supporting the licence application for eslicarbazepine come from three pivotal studies all similar in design, and a pooled analysis. 5,6,7,8 Further data from one-year open-label extension studies are available. 9,10,11 Two trials have been fully published to date; 5,7 all other studies are reported in conference abstracts. The three pivotal studies 5,6,7 were multicentre, randomised, placebocontrolled, parallel-group trials which included an 8 week baseline period followed by a double-blind 2 week titration, a 12 week and, in two studies, a 4 week tapering-off period. 5,7 Patients aged 18 years or older with refractory partial-onset seizures (simple or complex, with or without secondary generalisation), with 4 partial-onset seizures per 4 weeks in the baseline period whilst on treatment with one to three concurrent AEDs (but not oxcarbazepine or felbamate) were included. The primary outcome measure in all three studies was seizure frequency for the 12 week standardised to a frequency per 4 weeks unit. Secondary endpoints included proportion of responders (patients with a 50% reduction in seizure frequency in the maintenance period) and relative reduction in seizure frequency.

2 In studies BIA and 302 6, patients were randomised to treatment with placebo, eslicarbazepine 400mg, 800mg, or 1,200mg once daily in addition to their usual AEDs. In study the ITT population included 397 patients and 330 completed the study. In study 302 6, 393 were included in the ITT population. The number of patients completing the study was not stated. In study 303 7, 252 patients were randomised to treatment with placebo, eslicarbazepine 800mg or 1,200mg once daily. 7 The ITT population included 245 patients and 194 completed the study. Across the three studies, discontinuation rates due to adverse effects were 4.5%, 11.6%, and 19.3% in the placebo, groups, respectively. 2 In all three studies there was a statistically significant improvement in the primary outcome for the groups compared to placebo, but not for the eslicarbazepine 400mg group. The CHMP raised concerns about study 303 due to a high percentage of major protocol violations (34%) and considered some results implausible. 2 See Table 1 for results. Data from these studies were integrated in a pooled analysis. 8 The mean standardised seizure frequency at baseline was approximately 13 seizures per 4 weeks in all treatment groups. There was a statistically significant decrease to 9.8 (± 14.79) and 9.0 (± 13.10) in the eslicarbazepine 800mg and 1,200mg groups, respectively, compared with 11.7 (± 17.85) in the. The proportion of responders was 22%, 36%, and 44% in the placebo, groups, respectively. All three studies included an optional open-label extension period of one year. Patients received eslicarbazepine (median dose 800mg once daily, n=830). 29% of patients included received placebo in the initial studies. 9,10,11 Compared to the baseline period of the RCTs seizure frequency was decreased by 41%, 39% and 58% in weeks 41 to 52 of extension studies 301, 302, and 303, respectively (see Table 2 for results). Treatment-related adverse effects were reported by 51% to 83% of patients. 9,10,11 This led to treatment discontinuation in 4% to 11% of patients. 9,10 There were limitations to these studies. The CHMP requested further analyses due to inconsistencies in the data. However, overall results from these additional analyses were consistent with the original results. 2 The most frequent concomitant AEDs at the end of the baseline period were carbamazepine (56%), sodium valproate (24%) and lamotrigine (21%). In the pooled analysis approximately 70% of patients were on two concomitant AEDs. Only 3% were on three AEDs. 2 The percentage of patients with 25% increase in seizure frequency was slightly higher in the eslicarbazepine 1,200mg group vs. the 800mg group in some studies. However, following further analysis the CHMP concluded that there is no indication of potential exacerbation of seizures. 2 In one extension study quality of life (QOL), as assessed by QOL in Epilepsy Inventory- 31, and depressed mood, as assessed by Montgomery-Asberg Depression Rating Scale showed clinical and statistical improvement from baseline. 12 Safety Eslicarbazepine has a similar adverseeffect profile to oxcarbazepine. The most common adverse effects are dizziness, somnolence, headache, diplopia, nausea and abnormal coordination and occur mainly during the first six weeks of treatment. 1 These are more frequent in patients treated concurrently with carbamazepine than those who are not (dizziness 30% vs. 11.5%, diplopia 11.4% vs. 2.4%, abnormal coordination 6.7% vs. 2.7%). 2 Eslicarbazepine is a weak inducer of CYP3A4 and an inhibitor of CYP2C19 hepatic enzymes. Dose adjustments may be needed if eslicarbazepine is given concurrently with medicines metabolised by these enzymes (see SPC for details). 1 In clinical trials ECG changes were recorded in patients treated with eslicarbazepine. Therefore Zebinix is contraindicated in patients with second and third degree atrioventricular block and should be used with caution in patients with medical conditions or on concurrent medication associated with PR prolongation. 1 Rash occurred in 1.1% of patients in clinical trials. 1 There were no reports of severe skin reactions such as Stevens-Johnson syndrome (SJS), but there have been reports with oxcarbazepine. The SPC for Zebinix states that people of Han Chinese and Thai origin should be screened for allele HLA-B*1502 before starting treatment as this is a risk factor for SJS. 1 NHS Impact Approximately 456,000 people in the UK have epilepsy (2003 data) with an annual incidence of 46 per 100, An average GP will care for 15 people with epilepsy and see one to two new cases per year. 13 In clinical trials eslicarbazepine was more effective than placebo at a dose of 800mg or 1,200mg once daily as add-on treatment in patients receiving one or more AEDs in the management of simple and complex partial-onset seizures with or without secondary generalisation. There are no activecomparator trials. Eslicarbazepine is an addition to the available AEDs for patients with refractory epilepsy. It is given once daily which may improve compliance. A high percentage of patients in trials experienced adverse effects. Most adverse effects are mild and occur within the first few weeks. Further trials are needed to ascertain if eslicarbazepine offers any advantages over other AEDs in terms of efficacy, safety and QOL. It may be an alternative for patients who have not responded well to other treatments although it is not clear which patients would benefit most. The Scottish Medicines Consortium has rejected eslicarbazepine for use within NHS Scotland for the licensed indication. 14 Currently there are no published economic analyses however, compared with alternative AEDs eslicarbazepine is expensive. An update to NICE guidance on epilepsy is expected in November Table 1: Clinical trials of eslicarbazepine vs. placebo Table 2: Data from oneyear extension studies Risk Management Issues: Patients on warfarin: monitor INR carefully in the first weeks after starting concurrent treatment with eslicarbazepine. Produced for the UK Medicines Information Service By Lindsay Banks North West Medicines Information Centre, 70 Pembroke Place, Liverpool L69 3GF The information contained in this document will be superseded in due course. Not to be used for commercial purposes. May be copied for use within the NHS.

3 References 1. Summary of Product Characteristics: Zebinix. Eisai Limited. April Accessed at 27/11/ Zebinix.European Public Assessment Report (EPAR). Scientific discussion. February Accessed at /zebinix/h-988-en6.pdf 27/11/ National Institute for Health and Clinical Excellence. NICE TA76; Newer drugs for epilepsy in adults. March Accessed at 27/11/ Joint Epilepsy Council. Epilepsy prevalence, incidence and other statistics. August Elger C, Halasz P, Maia J et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partialonset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia 2009; 50 (3): Hufnagel A, Ben-Menachem E, Gabbai AA et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA study. Epilepsia 2008; 49 (Suppl 7): Gil-Nagel A, Lopes-Lima J, Almeida L et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partialonset seizures. Acta Neurol Scand 2009: 120: Elger C, French J, Halasz P et al. Evaluation of eslicarbazepine acetate as add-on treatment in patients with partial-onset seizures: Pooled analysis of three double-blind phase III clinical studies. Epilepsia 2008; 49 (Suppl 7): Guekht A, Elger C, Halasz P et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate: results of a 1 year open-label extension study. Epilepsia 2009; 50 (Suppl 4): Gabbai AA, Ben-Menachem E, Maia J et al. Longterm treatment of partial epilepsy with eslicarbazepine acetate (ESL): Results of a one-year open-label extension of study BIA Epilepsia 2008; 49 (Suppl 7): Lopes-Lima J, Gil-Nagel A, Maia J et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate (ESL): Results of a one-year open-label extension of study BIA Epilepsia 2008; 49 (Suppl 7): Cramer J, Elger C, Halasz P et al. Improvement in quality-of-life and depressive symptoms during longterm treatment with eslicarbazepine acetate: BIA study. Epilepsia 2008; 49 (Suppl 7): National Institute for Health and Clinical Excellence. NICE CG20; Epilepsy in adults and children. October Accessed at sh 27/11/ Scottish Medicines Consortium. Eslicarbazepine acetate 800mg tablets (Zebinix ) No.(592/09). Januray Accessed at 20acetate%20(Zebinix)%20FINAL%20December% doc%20for%20website.pdf 11/02/2010. Key papers are highlighted in bold

4 Table 1: Clinical trials of eslicarbazepine vs. placebo in adults with refractory partial-onset epilepsy. Reference Inclusion/Exclusion Criteria Population data Efficacy outcome Results: ITT population Inclusion criteria n=397 Placebo Eslicarbazepine Eslicarbazepine Eslicarbazepine BIA years of age 400mg daily 800mg daily 1,200mg daily diagnosis of simple or Mean ± SD baseline seizure complex partial seizures with or 12.4 ± ± ± ± without secondary Primary outcome generalisation for at least (6.78 to 8.58) (5.93 to 7.60) (4.92 to 6.45) (4.63 to 6.12) 4 partial-onset seizures in () each 4 week period during 8 p=ns p<0.01 p<0.001 weeks prior to screening and no Secondary outcomes seizure-free interval exceeding 21 consecutive days. 20% 23% 34% 43% treatment with 1 or 2 AEDs* Median relative reduction in seizure (not oxcarbazepine or 16% 26% 36% 45% frequency () felbamate) in a stable dosage regimen for at least 2 months n=393 Primary outcome BIA prior to screening not pregnant/breastfeeding (8.7 to 11.1) (7.7 to 9.9) (6.2 to 8.2) (6.0 to 8.1) and using acceptable () p=ns p<0.01 p<0.001 contraception Secondary outcome Exclusion criteria simple partial seizures 18.% 19.8% 32% 35.1% without motor symptoms. n=245 Mean ± SD baseline seizure primarily generalised BIA ± N/A 11.6 ± ± epilepsy. known rapid progressive Primary outcome neurological disorder history of status epilepticus (6.3 to 8.5) N/A (4.9 to 6.7) (4.6 to 6.5) or cluster seizures within 3 () p=0.048 p=0.021 Secondary outcome history of schizophrenia or attempted suicide. 22.6% N/A 34.5% 37.7% seizures of psycogenic Pooled n=1,035 Mean ± SD baseline seizure origin within the last 2 years analysis ± ± ± ± second or third-degree Mean ± SD seizure frequency per 4 atrioventricular not corrected ± ± ± ± week period () with a pacemaker relevant clinical laboratory 21.5% 22.9% 36.3% 43.5% abnormalities (n=986) exposure to oxcarbazepine Median relative reduction in seizure or felbamate within one month frequency () of screening. (n=983) 14.6% 23.4% 35.4% 38.8% *1 to 3 AEDs in study 302, p values stated = comparison to placebo LS=Least square Responder rate = patients with a 50% reduction in seizure frequency in the.

5 Table 2: Data from one-year extension studies of eslicarbazepine in adults with refractory partial-onset epilepsy Reference Inclusion/Exclusion Criteria Population data Efficacy outcome Results: ITT population Eslicarbazepine median 800mg daily study study study Inclusion criteria 18 years of age diagnosis of simple or complex partial seizures with or without secondary generalisation for at least 12 4 partial-onset seizures in each 4 week period during 8 weeks prior to screening and no seizure-free interval exceeding 21 consecutive days. treatment with 1 or 2 AEDs* (not oxcarbazepine or felbamate) in a stable dosage regimen for at least 2 months prior to screening. not pregnant/breastfeeding and using acceptable contraception Exclusion criteria simple partial seizures without motor symptoms. primarily generalised epilepsy. known rapid progressive neurological disorder. history of status epilepticus or cluster seizures within 3 months prior to screening. history of schizophrenia or attempted suicide. seizures of psycogenic origin within the last 2 years second or third-degree atrioventricular blockade not corrected with a pacemaker relevant clinical laboratory abnormalities exposure to oxcarbazepine or felbamate within one month of screening. n= (25.5%) n= (28.9%) n= (33.5%) Weeks 1 to 4 Weeks 5 to 16 Weeks 41 to 52 32% 38% 41% Responder rate 41% 48 to 53% per 12 week interval 32% 38% 39% Responder rate 37% 38 to 42% per 12 week interval 48% 54% 58% Responder rate 46% 52 to 56% per 12 week interval *1 to 3 AEDs in study 302, Responder rate = patients with a 50% reduction in seizure frequency in the

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