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Eslicarbazepine

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1. Eslicarbazepine acetate (Zebinix) - epilepsy

Eslicarbazepine acetate (Zebinix) - epilepsy Final Appraisal Recommendation Advice No: 1019 – June 2019 Eslicarbazepine acetate (Zebinix ® ) 200 mg and 800 mg tablets, and 50 mg/ml oral suspension Limited submission by Eisai Ltd Additional note(s): • This advice incorporates and replaces the existing AWMSG recommendation for eslicarbazepine acetate (Zebinix ® ) as an option for restricted use within NHS Wales. Eslicarbazepine acetate should be restricted to treatment of highly refractory (...) Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Eslicarbazepine acetate (Zebinix ® ) is recommended as an option for restricted use within NHS Wales. Eslicarbazepine acetate

2019 All Wales Medicines Strategy Group

2. Eslicarbazepine acetate add-on for drug-resistant partial epilepsy. (PubMed)

Eslicarbazepine acetate add-on for drug-resistant partial epilepsy. This is an updated version of the Cochrane Review published in the Cochrane Library 2011, Issue 12.The majority of people with epilepsy have a good prognosis, but up to 30% of people continue to have seizures despite several regimens of antiepileptic drugs. In this review, we summarized the current evidence regarding eslicarbazepine acetate (ESL) when used as an add-on treatment for drug-resistant partial epilepsy.To evaluate

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2017 Cochrane

3. Effects of adjunctive eslicarbazepine acetate on serum lipids in patients with partial-onset seizures: Impact of concomitant statins and enzyme-inducing antiepileptic drugs. (PubMed)

Effects of adjunctive eslicarbazepine acetate on serum lipids in patients with partial-onset seizures: Impact of concomitant statins and enzyme-inducing antiepileptic drugs. To evaluate the effects of eslicarbazepine acetate (ESL) on lipid metabolism and to determine whether reduced statin exposure during ESL therapy has clinical consequences.We conducted a post-hoc analysis of pooled data for serum lipids (laboratory values) from three phase III, multicenter, randomized, double-blind, placebo

2019 Epilepsy research

4. Health-related quality of life in patients treated with eslicarbazepine acetate monotherapy: Pooled analysis from two registered clinical trials. (PubMed)

Health-related quality of life in patients treated with eslicarbazepine acetate monotherapy: Pooled analysis from two registered clinical trials. While antiepileptic drug (AED) treatment effectiveness is traditionally assessed based on seizure frequency reduction (SFR), the overall value of AEDs in managing epilepsy and associated sequelae may be best assessed by how patients feel and function in terms of overall health-related quality of life (HRQoL). We conducted a pooled analysis (...) of the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire from two phase 3 trials to explore the effect of response to conversion to eslicarbazepine acetate (ESL) monotherapy on HRQoL.Data were pooled from two multicenter, randomized, double-blind, historical control phase 3 trials examining conversion to ESL monotherapy in adults with inadequately controlled partial-onset seizures (POS). The relationship between HRQoL and ESL treatment response was examined through the analysis of week 18 QOLIE-31

2019 Epilepsy & behavior : E&B

5. Eslicarbazepine acetate (Zebinix) - as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures

Eslicarbazepine acetate (Zebinix) - as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures Published 11 February 2019 Product Update: eslicarbazepine acetate 200mg and 800mg tablets and oral suspension 50mg/mL (Zebinix ® ) SMC2087 Eisai Ltd 10 August 2018 (Issued 11 January 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use (...) in NHS Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission eslicarbazepine acetate (Zebinix ® ) is accepted for restricted use within NHSScotland. Indication under review: as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation. SMC restriction: patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs. SMC

2019 Scottish Medicines Consortium

6. Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine

Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized (...) , double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine Zaccara G, Giovannelli F, Maratea D, Fadda V, Verrotti A CRD summary The authors concluded that antiepileptic drugs may cause neurological adverse events in patients with drug resistant epilepsy, which can limit their use and impair treatment success; higher doses of oxcarbazepine were associated with more frequent adverse events. The evidence had several limitations and the findings were not weighed against drug

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2013 DARE.

7. Influence of titration schedule and maintenance dose on the tolerability of adjunctive eslicarbazepine acetate: An integrated analysis of three randomized placebo-controlled trials. (PubMed)

Influence of titration schedule and maintenance dose on the tolerability of adjunctive eslicarbazepine acetate: An integrated analysis of three randomized placebo-controlled trials. To examine the influence of titration schedule and maintenance dose on the incidence and type of treatment-emergent adverse events (TEAEs) associated with adjunctive eslicarbazepine acetate (ESL).Data from three randomized, double-blind, placebo-controlled trials were analyzed. Patients with refractory partial-onset

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2018 Epilepsy research

8. Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures. (PubMed)

Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures. This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS).Children (6-16years old) with FOS were randomized (2:1) to ESL or placebo. Treatment started at 10mg/kg/day, was up-titrated up to 30mg

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2018 Epilepsy & behavior : E&B

9. Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures. (PubMed)

Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures. To evaluate and compare the effects of concomitant lamotrigine (LTG) or carbamazepine (CBZ) on the incidence of treatment-emergent adverse events (TEAEs) in patients taking adjunctive eslicarbazepine acetate (ESL) for focal (partial-onset) seizures (FS).These post-hoc analyses of data pooled

2018 Epilepsy research

10. Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia. (PubMed)

Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia. Antiepileptic drugs are the first-line treatment for trigeminal neuralgia (TN). Carbamazepine and oxcarbazepine are the most studied with well-known efficacy. Eslicarbazepine acetate is a third-generation antiepileptic drug that has not previously been evaluated for the treatment of TN. We aim to assess the efficacy, tolerability and safety of eslicarbazepine for TN.Retrospective, open-label (...) , multicentric, intention-to-treat study. We included patients older than 18 years who met the ICHD-3 beta diagnostic criteria for TN. We evaluated the variation of intensity and frequency of pain paroxysms before and after treatment with eslicarbazepine. Secondary objectives assessed were tolerability and safety of eslicarbazepine.Eighteen patients were included, 15 women, mean age 65.2 years old, mean follow-up 21.1 months. The mean number of drugs tested before eslicarbazepine was 2; 10 patients used

2018 European Journal of Pain

11. Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. (PubMed)

Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study. We assessed the efficacy and safety of once-daily eslicarbazepine acetate in comparison with twice-daily (BID) controlled-release carbamazepine (carbamazepine-CR) monotherapy in newly diagnosed focal epilepsy patients.This randomized, double-blind, noninferiority trial (NCT01162460) utilized (...) a stepwise design with 3 dose levels. Patients who remained seizure-free for the 26-week evaluation period (level A: eslicarbazepine acetate 800 mg/carbamazepine-CR 200 mg BID) entered a 6-month maintenance period. If a seizure occurred during the evaluation period, patients were titrated to the next target level (level B: eslicarbazepine acetate 1200 mg/carbamazepine-CR 400 mg BID, level C: eslicarbazepine acetate 1600 mg/carbamazepine-CR 600 mg BID) and the evaluation period began again. The primary

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2018 Epilepsia

12. Effects of eslicarbazepine on slow inactivation processes of sodium channels in dentate gyrus granule cells. (PubMed)

Effects of eslicarbazepine on slow inactivation processes of sodium channels in dentate gyrus granule cells. Pharmacoresistance is a problem affecting ∼30% of chronic epilepsy patients. An understanding of the mechanisms of pharmacoresistance requires a precise understanding of how antiepileptic drugs interact with their targets in control and epileptic tissue. Although the effects of (S)-licarbazepine (S-Lic) on sodium channel fast inactivation are well understood and have revealed maintained

2018 Epilepsia

13. Eslicarbazepine acetate (Zebinix) - treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy

Eslicarbazepine acetate (Zebinix) - treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy Non Submission eslicarbazepine acetate 200mg and 800mg tablets (Zebinix ® ) SMC2090 Eisai Ltd 4 May 2018 ADVICE: in the absence of a submission from the holder of the marketing authorisation eslicarbazepine acetate (Zebinix ® ) is not recommended for use within NHS Scotland. Indication under review: As monotherapy in the treatment of partial

2018 Scottish Medicines Consortium

14. Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine. (PubMed)

Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine. To evaluate the influence of prior use of carbamazepine (CBZ) and other antiepileptic drugs (AEDs) with a putatively similar mechanism of action (inhibition of voltage-gated sodium channels; VGSCs) on seizure outcomes and tolerability when converting to eslicarbazepine acetate (ESL), using data pooled from 2 controlled conversion-to-ESL monotherapy trials (studies: 093-045, 093-046).Adults

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2018 Epilepsia

15. Comment on a paper by Sanchez-Larsen A et al. "Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia". (PubMed)

Comment on a paper by Sanchez-Larsen A et al. "Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia". 29575409 2018 12 11 2018 12 11 1532-2149 22 6 2018 07 European journal of pain (London, England) Eur J Pain Comment on a paper by Sanchez-Larsen A et al. 'Assessment of efficacy and safety of eslicarbazepine acetate for the treatment of trigeminal neuralgia'. 1188-1189 10.1002/ejp.1219 Alcántara Montero A A Pain Unit, Hospital Don Benito (...) -Villanueva de la Serena, Don Benito (Badajoz), Spain. Sánchez Carnerero C I CI Complejo Hospitalario Universitario de Cáceres, Hospital San Pedro de Alcántara, Cáceres, Spain. eng Letter Comment England Eur J Pain 9801774 1090-3801 0 Dibenzazepines BEA68ZVB2K eslicarbazepine acetate IM Eur J Pain. 2018 Jul;22(6):1080-1087 29369456 Dibenzazepines Humans Trigeminal Neuralgia 2018 03 14 2018 3 27 6 0 2018 12 12 6 0 2018 3 26 6 0 ppublish 29575409 10.1002/ejp.1219

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2018 European Journal of Pain

16. Eslicarbazepine acetate in epilepsies with focal and secondary generalised seizures: systematic review of current evidence.

Eslicarbazepine acetate in epilepsies with focal and secondary generalised seizures: systematic review of current evidence. Eslicarbazepine acetate (ESL) is a third-generation antiepileptic drug (AED) approved for adjunctive treatment in adults, children, and adolescents with focal-onset seizures. Recently ESL was approved for initial monotherapy in adults. The intention of this article is to review current evidence for ESL and to summarise its pharmacological profile in comparison to other (...) AEDs of the dibenzazepine group. Areas covered: We performed a systematic literature search in electronic databases (MEDLINE database, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE) using a combined search strategy including the following keywords: eslicarbazepine, epilepsy and seizure. The search was performed from 2000 until December 2017. Using a standardised assessment form, information on the study design, methodological framework, data sources and efficacy

2018 Expert review of clinical pharmacology

17. Adjunctive eslicarbazepine acetate: A pooled analysis of three phase III trials.

Adjunctive eslicarbazepine acetate: A pooled analysis of three phase III trials. To assess the safety and efficacy of once-daily (QD) adjunctive eslicarbazepine acetate (ESL).This post-hoc pooled analysis of three randomized, placebo-controlled trials (2093-301, -302, -304) involved adults with refractory partial-onset seizures (POS) receiving 1-3 antiepileptic drugs (AEDs). All studies included 8-week baseline, 2-week titration, and 12-week maintenance periods. Patients were randomized equally

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2018 Epilepsy & behavior : E&B

18. Adjunctive Eslicarbazepine Acetate in Pediatric Patients with Focal Epilepsy: A Systematic Review and Meta-Analysis.

Adjunctive Eslicarbazepine Acetate in Pediatric Patients with Focal Epilepsy: A Systematic Review and Meta-Analysis. In the treatment of pediatric epilepsy, there is a critical demand for effective and safe therapeutic options to address patients' unmet clinical needs. Eslicarbazepine acetate is a novel once-daily antiepileptic drug and a third-generation single enantiomer member of the dibenzazepine family.The objective of this study was to evaluate the efficacy and safety of eslicarbazepine (...) acetate as add-on treatment for focal-onset seizures in pediatric patients using meta-analytical techniques.Randomized, placebo-controlled, single- or double-blinded add-on trials of eslicarbazepine acetate in patients < 18 years of age with focal-onset seizures uncontrolled by concomitant stable antiepileptic drug regimens were identified through a systematic literature search. The assessed outcomes included the mean relative change and ≥ 50% reduction in the baseline seizure frequency, the incidence

2018 CNS drugs

19. Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures (PubMed)

Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures Modeling and simulations were used to support body weight-based dose selection for eslicarbazepine acetate (ESL) in pediatric subjects aged 4-17 years with partial-onset seizures. A one-compartment pediatric population pharmacokinetic model with formulation-specific first-order absorption, first-order elimination, and weight-based allometric scaling (...) indicated no substantial bias in the overall model and in the accuracy of estimates. The model estimated that concomitant use of carbamazepine or phenobarbital-like AEDs with ESL would decrease the exposure of eslicarbazepine, and that concomitant use of levetiracetam with ESL would increase the exposure of eslicarbazepine, although the small effect of levetiracetam may not represent a true difference. Model-based simulations were subsequently performed to apply target exposure matching of selected ESL

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2018 Journal of pharmacokinetics and pharmacodynamics

20. Exposure‐safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate (PubMed)

Exposure‐safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) for focal-onset seizures (FOS). Pharmacokinetic (PK) and pharmacodynamic (PD) models were developed to assess dose selection, identify significant AED drug interactions, and quantitate relationships between exposure and safety and efficacy outcomes from Phase 3 trials of adjunctive ESL.Eslicarbazepine (...) (the primary active metabolite of ESL) population PK was evaluated using data from 1351 subjects enrolled in 14 studies (11 Phase 1 and three Phase 3 studies) after multiple oral doses ranging from 400 to 1200 mg. Population PK and PD models related individual eslicarbazepine exposures to safety outcomes and efficacy responses.Eslicarbazepine PK was described by a one-compartment model with linear absorption and elimination. The probability of a treatment-emergent adverse event (TEAE; dizziness, headache

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2018 Acta neurologica Scandinavica

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