New Medicines Profile
|
|
- Doris Burns
- 5 years ago
- Views:
Transcription
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
eslicarbazepine acetate 800mg tablet (Zebinix) SMC No. (592/09) Eisai Ltd
eslicarbazepine acetate 800mg tablet (Zebinix) SMC No. (592/09) Eisai Ltd 8 October 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards
More information2. SYNOPSIS Name of Sponsor/Company:
in patients with refractory partial seizures 14 Jun 2007 2. SYNOPSIS TITLE OF STUDY: Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomized,
More informationlevetiracetam 250,500,750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra ) (No. 397/07) UCB Pharma Ltd
Scottish Medicines Consortium Resubmission levetiracetam 250,500,750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra ) (No. 397/07) UCB Pharma Ltd 11 January 2008 The Scottish Medicines
More informationScottish Medicines Consortium
Scottish Medicines Consortium levetiracetam, 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra ) No. (394/07) UCB Pharma Limited 10 August 2007 The Scottish Medicines Consortium
More informationEfficacy of Levetiracetam: A Review of Three Pivotal Clinical Trials
Epilepsia, 42(Suppl. 4):31 35, 2001 Blackwell Science, Inc. International League Against Epilepsy Efficacy of : A Review of Three Pivotal Clinical Trials Michael Privitera University of Cincinnati Medical
More informationNew antiepileptic drugs
Chapter 29 New antiepileptic drugs J.W. SANDER UCL Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery, Queen Square, London, and Epilepsy Society, Chalfont
More informationHelena Gama 1 Mariana Vieira. Luís M. Magalhães 1 Patrício Soares-da-Silva
Drug Saf (2017) 40:1231 1240 DOI 10.1007/s40264-017-0576-4 ORIGINAL RESEARCH ARTICLE Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical
More informationScottish Medicines Consortium
Scottish Medicines Consortium pregabalin, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules (Lyrica ) No. (389/07) Pfizer Limited 6 July 2007 The Scottish Medicines Consortium has completed
More informationOpinion 24 July 2013
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 24 July 2013 FYCOMPA 2 mg, film-coated tablet B/7 (CIP: 34009 267 760 0 8) B/28 (CIP: 34009 268 447 4 5) FYCOMPA 4
More informationNew AEDs in Uncontrolled seizures
New AEDs in Uncontrolled seizures Uncontrolled seizures/epilepsy Intractable epilepsy, Refractory epilepsy, Pharmacoresistant epilepsy Dr. Suthida Yenjun Traditionally, referred to therapeutic failure
More informationLMMG New Medicine Recommendation
LMMG New Medicine Recommendation Oxcarbazepine (Trileptal ) for the treatment of epilepsy LMMG Recommendation: Amber 0: Oxcarbazepine (Trileptal ) is recommended for use as monotherapy or adjunctive therapy
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 05 May 2010
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 05 May 2010 LAMICTAL 2 mg, dispersible / chewable tablet B/30 (CIP: 354 581-7) LAMICTAL 5 mg, dispersible / chewable
More informationLacosamide (Vimpat) for partial-onset epilepsy monotherapy. December 2011
Lacosamide (Vimpat) for partial-onset epilepsy monotherapy This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a
More informationSODIUM CHANNEL BLOCKERS IN THE 21 ST CENTURY. Professor Martin J Brodie University of Glasgow Glasgow, Scotland
IN THE 21 ST CENTURY Professor Martin J Brodie University of Glasgow Glasgow, Scotland Eisai SODIUM CHANNEL BLOCKERS Declaration of interests UCB Pharma GlaxoSmithKline Lundbeck Takeda Advisory board,
More informationTRANSPARENCY COMMITTEE OPINION. 19 July 2006
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 19 July 2006 Keppra 250 mg, film-coated tablets Box of 60 tablets (CIP code: 356 013-6) Keppra 500 mg, film-coated
More informationPEDIATRIC PHARMACOTHERAPY
PEDIATRIC PHARMACOTHERAPY A Monthly Newsletter for Health Care Professionals from the Children s Medical Center at the University of Virginia Volume 7 Number 11 November 2001 A Oxcarbazepine Use in Children
More informationFDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types
FOR IMMEDIATE RELEASE FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types Carnexiv is the first FDA-approved intravenous carbamazepine
More informationroflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd
roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd 06 August 2010 (Issued 10 September 2010) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationasenapine 5mg, 10mg sublingual tablet (Sycrest ) SMC No. (762/12) Lundbeck Ltd
asenapine 5mg, 10mg sublingual tablet (Sycrest ) SMC No. (762/12) Lundbeck Ltd 10 February 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS
More informationResubmission. Scottish Medicines Consortium
Scottish Medicines Consortium Resubmission aripiprazole 5mg, 10mg, 15mg, 0mg tablets; 10mg, 15mg orodispersible tablets; 1mg/mL oral solution (Abilify ) No. (498/08) Bristol-Myers Squibb Pharmaceuticals
More informationProduct Availability: FDA approved November Anticipated availability is late
Brand Name: Aptiom Generic Name: eslicarbazepine Manufacturer: Sunovion Pharmaceuticals Inc 1 Product Availability: FDA approved November 2013. Anticipated availability is late 2014. 2 Drug Class: Anticonvulsant,
More informationEfficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a historicalcontrol
Jacobson et al. BMC Neurology (2015) 15:46 DOI 10.1186/s12883-015-0305-5 RESEARCH ARTICLE Open Access Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled
More informationSafety and Efficacy of Oxcarbazepine: Results of Randomized, Double-Blind Trials
Safety and Efficacy of Oxcarbazepine: Results of Randomized, Double-Blind Trials Ahmad Beydoun, M.D. Oxcarbazepine is approved as monotherapy and adjunctive therapy for partial seizures with and without
More informationsodium oxybate, 500mg/ml oral solution (Xyrem) No. (246/06) UCB Pharma Ltd
Scottish Medicines Consortium Resubmission sodium oxybate, 500mg/ml oral solution (Xyrem) No. (246/06) UCB Pharma Ltd 10 August 2007 The Scottish Medicines Consortium has completed its assessment of the
More informationSuffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)
Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Zebinix 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of eslicarbazepine acetate.
More information2018 American Academy of Neurology
Practice Guideline Update Efficacy and Tolerability of the New Antiepileptic Drugs II: Treatment-Resistant Epilepsy Report by: Guideline Development, Dissemination, and Implementation Subcommittee of the
More informationRefractory epilepsy: treatment with new antiepileptic drugs
Seizure 2000; 9: 51 57 doi: 10.1053/seiz.1999.0348, available online at http://www.idealibrary.com on Refractory epilepsy: treatment with new antiepileptic drugs P. K. DATTA & P. M. CRAWFORD Department
More informationLondon, 07 August 2006 Product name: Keppra Procedure No. EMEA/H/C/277/II/63 SCIENTIFIC DISCUSSION
London, 07 August 2006 Product name: Keppra Procedure No. EMEA/H/C/277/II/63 SCIENTIFIC DISCUSSION 1/15 EMEA 2006 1. Introduction Epilepsy is one of the most common and challenging neurological disorders.
More informationThe limited submission criteria were met based on a minor licence extension and anticipated minimal budgetary impact in NHS Wales
AWMSG Secretariat Assessment Report Limited submission Brivaracetam (Briviact ) 10 mg, 25 mg, 50 mg, 75 mg and 100 mg film-coated tablets; 10 mg/ml oral solution; 10 mg/ml solution for injection/infusion
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationNewer AEDs compared to LVT as adjunctive treatments for uncontrolled focal epilepsy. Dr. Yotin Chinvarun. M.D. Ph.D.
Newer AEDs compared to LVT as adjunctive treatments for uncontrolled focal epilepsy Dr. Yotin Chinvarun. M.D. Ph.D. Chronology of antiepileptic drug introduction over the past 150 years 20 15 10 Perampanel
More informationScottish Medicines Consortium
Scottish Medicines Consortium rotigotine 2mg/24 hours, 4mg/24 hours, 6mg/24 hours, 8mg/24 hours transdermal patch (Neupro ) (No: 289/06) Schwarz Pharma Ltd. 7 July 2006 The Scottish Medicines Consortium
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Zebinix 800 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800 mg of eslicarbazepine acetate.
More informationPRODUCT MONOGRAPH. eslicarbazepine acetate. 200 mg, 400 mg, 600 mg and 800 mg Tablets. Professed. Antiepileptic
PRODUCT MONOGRAPH Pr APTIOM eslicarbazepine acetate 00 mg, 400 mg, 600 mg and 800 mg Tablets Professed Antiepileptic Sunovion Pharmaceuticals Canada Inc. 6790 Century Ave., Suite 100 Mississauga, Ontario
More informationLead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984]
Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984] 1 st Appraisal Committee meeting Background & Clinical Effectiveness John McMurray 11 th January 2016 For
More informationMONOTHERAPY IS PREferred
Monotherapy in Epilepsy Role of the Newer Antiepileptic Drugs Blanca Vazquez, MD NEUROLOGICAL REVIEW Background: Monotherapy is the goal for pharmacological treatment of epilepsy. Well-controlled trials
More informationDouble-blind, placebo controlled, crossover study
448 48ournal of Neurology, Neurosurgery, and Psychiatry 1993;56:448-453 PAPERS Department of Clinical Pharmacology, Queen Elizabeth Hospital, Woodville, SA, G J Schapel Liverpool Hospital, Liverpool, NSW,
More informationEpilepsy and EEG in Clinical Practice
Mayo School of Professional Development Epilepsy and EEG in Clinical Practice November 10-12, 2016 Hard Rock Hotel at Universal Orlando Orlando, FL Course Directors Jeffrey Britton, MD and William Tatum,
More informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI)
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationTailoring therapy to optimize care for Epilepsy. Dr Tim Wehner National Hospital for Neurology and Neurosurgery London, UK For discussion only
Tailoring therapy to optimize care for Epilepsy Dr Tim Wehner National Hospital for Neurology and Neurosurgery London, UK For discussion only Disclosures Session (travel expenses) sponsored by Pfizer Premature
More informationTopiramate: new indication in migraine prophylaxis Savvas Hadjikoutis MD, MRCP
Topiramate: new indication in migraine prophylaxis Savvas Hadjikoutis MD, MRCP PRODUCT PROFILE Proprietary name: Topamax Constituent: topiramate Indication: prophylaxis of migraine headache; initiation
More informationUpdated advice for nurses who care for patients with epilepsy
NICE BULLETIN Updated advice for nurses who care for patients with epilepsy NICE provided the content for this booklet which is independent of any company or product advertised NICE BULLETIN Updated advice
More informationSHARED CARE GUIDELINE
SHARED CARE GUIDELINE Methylphenidate in the treatment of Attention Deficit Hyperactivity Disorder in Children, Young People and Adults Implementation Date: June 2015 Review Date: June 2017 This guidance
More informationEpilepsy Medications: The Basics
Epilepsy Medications: The Basics B R I A N A P P A V U, M D C L I N I C A L A S S I S T A N T P R O F E S S O R, D E P A R T M E N T O F C H I L D H E A L T H A N D N E U R O L O G Y, U N I V E R S I T
More informationAdvice following an Independent Review Panel (IRP)
Scottish Medicines Consortium Advice following an Independent Review Panel (IRP) Pregabalin 25, 50, 75, 100, 150, 200 and 300mg capsules (Lyrica ) Pfizer No. 157/05 7 July 2006 The Scottish Medicines Consortium
More informationEpilepsy: pharmacological treatment by seizure type. Clinical audit tool. Implementing NICE guidance
Epilepsy: pharmacological treatment by seizure type Clinical audit tool Implementing NICE guidance 2012 NICE clinical guideline 137 Clinical audit tool: Epilepsy (2012) Page 1 of 25 This clinical audit
More informationDOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 100 mg, 150 mg, and 200 mg; scored. (3.1, 16)
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS.
More informationRecent Clinical Trials of Third- Generation Antiepileptic Drugs
Recent Clinical Trials of Third- Generation Antiepileptic Drugs Beth M. Silverstein, DO North Shore University Hospital, North Shore Long Island Jewish Health System, Manhasset, New York Abstract Effective
More informationScottish Medicines Consortium
Scottish Medicines Consortium abatacept, 250mg powder for concentrate for solution (Orencia ) No. (400/07) Bristol Myers Squibb Pharmaceuticals Ltd 10 August 2007 The Scottish Medicines Consortium has
More informationEuropean Medicines Agency decision
EMA/43935/2015 European Medicines Agency decision P/0015/2015 of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine (acetate) (Zebinix) (EMEA-000696-PIP02-10-M05
More informationLAMICTAL XR (lamotrigine) extended-release tablets, for oral use Initial U.S. Approval: 1994
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR
More informationLAMICTAL GlaxoSmithKline
LAMICTAL GlaxoSmithKline Lamotrigine QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets: LAMICTAL, 25, 50, 100 and 200 mg. Dispersible/Chewable Tablets: LAMICTAL, 2, 5, 25, 50, 100 and 200 mg. PHARMACEUTICAL
More informationLamotrigine 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg dispersible/chewable tablets
Arrow - Lamotrigine Lamotrigine 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg dispersible/chewable tablets Presentation Arrow - Lamotrigine 2 mg White to off-white, round tablets embossed with 'LI' over '2'
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamotrigin Medochemie 25 mg tablets Lamotrigin Medochemie 50 mg tablets Lamotrigin Medochemie 100 mg tablets Lamotrigin Medochemie 200
More informationRECENT MAJOR CHANGES Warnings and Precautions, Hemophagocytic
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine)
More informationNew Drug Evaluation: brivaracetam [tablet and solution, oral; solution, intravenous]
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationAntiepileptics. Medications Comment Quantity Limit Carbamazepine. May be subject Preferred to quantity limit Epitol
Market DC Antiepileptics Override(s) Approval Duration Prior Authorization 1 year Step Therapy Quantity Limit *Indiana Medicaid See State Specific Mandate below *Maryland Medicaid See State Specific Mandate
More informationSee 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 11/2011
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine)
More informationShared Care Guideline. The Management of Epilepsies in Children
THE SOUTH YORKSHIRE & BASSETLAW Shared Care Guideline For The Management of Epilepsies in Children Shared care guideline developed by: Sheffield Children's NHS Foundation Trust; Dr P Baxter Consultant
More informationScottish Medicines Consortium
Scottish Medicines Consortium budesonide/formoterol 100/6, 200/6 turbohaler (Symbicort SMART ) No. (362/07) Astra Zeneca UK Limited 9 March 2007 (Issued May 2007) The Scottish Medicines Consortium (SMC)
More informationOXCARBAZEPINE. THERAPEUTICS Brands Trileptal see index for additional brand names. Generic? Yes
OXCARBAZEPINE THERAPEUTICS Brands Trileptal see index for additional brand names Generic? Yes Class Anticonvulsant, voltage-sensitive sodium channel antagonist Commonly Prescribed for (bold for FDA approved)
More informationA COMMON REFERENCE-BASED INDIRECT COMPARISON META-ANALYSIS OF ESLICARBAZEPINE VERSUS LACOSAMIDE AS ADD ON TREATMENTS FOR FOCAL EPILEPSY PROTOCOL
A COMMON REFERENCE-BASED INDIRECT COMPARISON META-ANALYSIS OF ESLICARBAZEPINE VERSUS LACOSAMIDE AS ADD ON TREATMENTS FOR FOCAL EPILEPSY PROTOCOL Francesco Brigo 1,2 1 Department of Neurological and Movement
More informationCurrent Review In Clinical Science. Perampanel: A Selective AMPA Antagonist for Treating Seizures
Current Review In Clinical Science Perampanel: A Selective AMPA Antagonist for Treating Seizures Gregory L. Krauss, MD Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD Address correspondence
More informationAppendix M Health Economic Evidence Extractions
Appendix M Health Economic Evidence Extractions Which AEDs are clinically effective and cost-effective for people with focal epilepsy with or without secondary generalisation seizures? Frew E, Sandercock
More informationCopyright 2010 Informa UK Limited Not for Sale or Commercial Distribution
Current Medical Research & Opinion Vol. 26, No. 6, 2, 1355 1362 3-7995 Article 5168a/47468 doi:.1185/3799374861 All rights reserved: reproduction in whole or part not permitted Original article Pharmacokinetic
More informationManagement pathway: Treatment of epilepsy in adults
Management pathway: Treatment of epilepsy in adults Key messages Summary of treatment regimens supported by CUHFT/PSHFT consultants to support GP s with prescribing responsibility of antiepileptic drugs.
More informationNo May 25, Eisai Co., Ltd.
No.16-35 May 25, 2016 Eisai Co., Ltd. EISAI TO LAUNCH IN-HOUSE DEVELOPED ANTIEPILEPTIC DRUG FYCOMPA (PERAMPANEL HYDRATE) AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET AND GENERALIZED TONIC-CLONIC SEIZURES IN
More informationSee 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: May 2009 LMT:2PI
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine)
More informationLacosamide: A New Antiepileptic Drug
Drug Review Lacosamide: A New Antiepileptic Drug Pankaj Kumar, Anurag Jhanjee, M.S. Bhatia Department of Psychiatry, University College of Medical Sciences and G.T.B Hospital, University of Delhi, Delhi
More informationGREATER MANCHESTER INTERFACE PRESCRIBING GROUP
GREATER MANCHESTER INTERFACE PRESCRIBING GROUP On behalf of the GREATER MANCHESTER MEDICINES MANAGEMENT GROUP SHARED CARE GUIDELINE FOR THE PRESCRIBING OF SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIs)
More informationSHARED CARE AGREEMENT: MELATONIN (CHILDREN)
NB: This document should be read in conjunction with the current Summary of Product Characteristics (SPC) where appropriate. DRUG AND INDICATION: Generic drug name: Formulations: MELATONIN 3mg immediate
More information2018 American Academy of Neurology
Practice Guideline Update Efficacy and Tolerability of the New Antiepileptic Drugs I: Treatment of New-Onset Epilepsy Report by: Guideline Development, Dissemination, and Implementation Subcommittee of
More informationEPILEPSY DIAGNOSIS. Investigations- EEG, MRI, CT, blood tests. Appendix 1 contains a guide to questions to help with diagnosis
EPILEPSY DIAGNOSIS All adults with a recent-onset suspected seizure should be seen urgently by a specialist. The seizure type(s) and epilepsy syndrome, aetiology and co-morbidity should be determined.
More informationAxitinib (renal) Note: in some patients it may be appropriate to increase the dose to 6mg BD before increasing to 7mg BD.
Axitinib (renal) Indication Treatment of advanced renal cell carcinoma after failure of treatment with a first-line tyrosine kinase inhibitor (UK licensed indication states sunitinib) or a cytokine. (NICE
More informationNASDAQ: ZGNX. Company Presentation. October 2017
NASDAQ: ZGNX Company Presentation October 2017 2 Forward Looking Statement Zogenix cautions you that statements included in this presentation that are not a description of historical facts are forward-looking
More informationZonisamide Should Be Considered a First-Line Antiepileptic Drug for Patients with Newly Diagnosed Partial Epilepsy
Current Literature In Clinical Science Zonisamide Should Be Considered a First-Line Antiepileptic Drug for Patients with Newly Diagnosed Partial Epilepsy Efficacy and Tolerability of Zonisamide Versus
More informationChapter 31-Epilepsy 1. public accountant, and has begun treatment with lamotrigine. In which of the following activities
Chapter 31-Epilepsy 1 Chapter 31. Epilepsy, Self-Assessment Questions 1. BW is a 28-year-old man recently diagnosed with partial seizures. He works as a certified public accountant, and has begun treatment
More informationStaging of Seizures According to Current Classification Systems December 10, 2013
Staging of Seizures According to Current Classification Systems December 10, 2013 Elinor Ben-Menachem, M.D.,Ph.D, Instituet of Clinical Neuroscience and Physiology, Sahlgren Academy, Goteborg University,
More informationRe-Submission. Scottish Medicines Consortium. erlotinib, 100 and 150mg film-coated tablets (Tarceva ) No. 220/05 Roche. 5 May 2006
Scottish Medicines Consortium Re-Submission erlotinib, 100 and 150mg film-coated tablets (Tarceva ) No. 220/05 Roche 5 May 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the
More informationInformation leaflet for primary care: Agomelatine
Information leaflet for primary care: Agomelatine Background information Agomelatine is an antidepressant indicated for the treatment of major depressive episodes in adults. Agomelatine is a melatonin
More informationFinal Appraisal Report. ) for the treatment of idiopathic Parkinson s disease. Ropinirole prolonged-release (Requip XL. GlaxoSmithKline UK
Final Appraisal Report Ropinirole prolonged-release (Requip XL ) for the treatment of idiopathic Parkinson s disease GlaxoSmithKline UK Advice No: 1409 August 2009 Recommendation of AWMSG Ropinirole prolonged-release
More informationumeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline
umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline 07 November 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationGREEN. Ropinirole Other PD treatments Benzodiazepines Opioids low potency Anticonvulsants Clonidine
New Medicine Report (Adopted by the CCG until review and futher notice) Document Status Traffic Light Decision PRAMIPEXOLE For restless legs syndrome Post Suffolk D&TC GREEN Prescribers Rating Possibly
More informationmg 25 mg mg 25 mg mg 100 mg 1
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationOn completion of this chapter you should be able to: list the most common types of childhood epilepsies and their symptoms
9 Epilepsy The incidence of epilepsy is highest in the first two decades of life. It falls after that only to rise again in late life. Epilepsy is one of the most common chronic neurological condition
More informationPerampanel: Getting AMPed for AMPA Targets
Perampanel: Getting AMPed for AMPA Targets Current Literature In Clinical Science Randomized Phase III Study 306: Adjunctive Perampanel for Refractory Partial-Onset Seizures. Krauss GL, Serratosa JM, Villanueva
More informationSummary Clinical Evaluation of Carisbamate for Adjunctive Use in Treatment of Partial Onset Seizures
Summary Clinical Evaluation of Carisbamate for Adjunctive Use in Treatment of Partial Onset Seizures J&J Pharmaceutical R&D Antiepileptic Drug Trials XI April 27 2011 Summary of Past Development Efficacy
More informationAED Treatment Approaches. David Spencer, MD Director, OHSU Epilepsy Center Professor, Department of Neurology
AED Treatment Approaches David Spencer, MD Director, OHSU Epilepsy Center Professor, Department of Neurology Audience Response Keypads Please utilize the keypad at your table to answer questions throughout
More informationAPPENDIX K Pharmacological Management
1 2 3 4 APPENDIX K Pharmacological Management Table 1 AED options by seizure type Table 1 AED options by seizure type Seizure type First-line AEDs Adjunctive AEDs Generalised tonic clonic Lamotrigine Oxcarbazepine
More informationNHS Kent and Medway Medicines Management. Dronedarone (Multaq ) Shared Care Guideline For Prescribing
NHS Kent and Medway Medicines Management Dronedarone (Multaq ) Shared Care Guideline For Prescribing Issue No: 2 Review Date (If Applicable): Accountable Officer: Heather Lucas Contact Details: 01233 618158
More informationScottish Medicines Consortium
Scottish Medicines Consortium raltegravir, 400mg film-coated tablet (Isentress) No. (461/08) Merck, Sharp and Dohme Limited 04 April 2008 The Scottish Medicines Consortium has completed its assessment
More informationRECENT MAJOR CHANGES Indications and Usage (1) 9/2017 Dosage and Administration (2) 9/2017 Warnings and Precautions (5) 9/2017
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use APTIOM safely and effectively. See full prescribing information for APTIOM. APTIOM (eslicarbazepine
More informationAn overview of reports on lacosamide
An overview of reports on lacosamide Introduction Lacosamide (Vimpat ) was registered for the European market on August 29th 2008. Since then Lareb has received several reports of possible adverse drug
More informationpaliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion) SMC No. (713/11) Janssen-Cilag Ltd
Re-Submission paliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion) SMC No. (713/11) Janssen-Cilag Ltd 07 October 2011 The Scottish Medicines Consortium
More informationScottish Medicines Consortium
Scottish Medicines Consortium sildenafil, 20mg (as citrate) tablets (Revatio ) No. (596/10) Pfizer Ltd 15 January 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of the above
More informationEvidence for a rapid action of levetiracetam compared to topiramate in refractory partial epilepsy
Seizure (2006) 15, 112 116 www.elsevier.com/locate/yseiz Evidence for a rapid action of levetiracetam compared to topiramate in refractory partial epilepsy Luigi M. Specchio a,e, *, Giovanni Boero b,e,
More informationScottish Medicines Consortium
Scottish Medicines Consortium eltrombopag, 25mg and 50mg film-coated tablets (Revolade ) No. (625/10) GlaxoSmithKline UK 09 July 2010 The Scottish Medicines Consortium (SMC) has completed its assessment
More informationPharmacy Medical Necessity Guidelines: Anticonvulsants/Mood Stabilizers
Pharmacy Medical Necessity Guidelines: Anticonvulsants/Mood Stabilizers Effective: December 18, 2017 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review
More information