Real-world EPOS Study Presented at the European Academy of Neurology Congress Shows Good Results in Retention Rates and Seizure Control for Epilepsy Treatment Zebinix® (eslicarbazepine acetate)
Once-daily Zebinix® (eslicarbazepine acetate), in routine clinical practice demonstrates good retention rates and seizure control, and is well-tolerated when given as an add-on to anti-epileptic monotherapy in adults[1], according to the primary results of the non-interventional EPOS (Eslicarbazepine acetate in Partial-Onset Seizure) study programme presented this week at the first Congress of the European Academy of Neurology (EAN) in Berlin, Germany. At six-months, the eslicarbazepine acetate retention rate was 82.2% (95% confidence interval [CI] 76.5-87%) and seizure freedom rate was at 39.2% (95% confidence interval [CI] 32.2-46.5%). Eslicarbazepine acetate is well tolerated with adverse events reported for 57 (26.0%) patients.[1]
The successful treatment of partial onset seizures (the most common type of epilepsy) remains a challenge. Currently, up to a third of people with epilepsy do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.[2] Eslicarbazepine acetate, a novel anti-epilepsy treatment for adult individuals with partial epilepsy, targets sodium channels, stabilising their inactive state. It is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.[3]
Additional EPOS study programme data presented at the congress demonstrates that eslicarbazepine acetate was effective, independent of the type of monotherapy treatment to which it was added.[4] Retention rate at six months, time to eslicarbazepine acetate discontinuation and responder rate (response defined as ≥50% seizure frequency reduction from baseline) were assessed according to the most frequent baseline monotherapies (>10% of patients).
Of 219 patients included in the study, 83, 54 and 30 received baseline monotherapy with levetiracetam (LEV), lamotrigine (LTG) and valproate (VAL), respectively. Retention rates (95% confidence intervals) at six months were 85.5% (76.1-92.3%) for LEV, 75.9% (62.4 - 86.5%) for LTG and 80.0% (61.4 - 92.3%) for VAL. Mean times to eslicarbazepine acetate discontinuation were 96.9 days (LEV), 90.8 days (LTG) and 88.8 days (VAL). Responder rates at six months ranged from 69.8% (LTG) to 88.5% (VAL). These data demonstrate that eslicarbazepine acetate as an add-on to antiepileptic monotherapy was effective independent of the type of monotherapy treatment to which it was added.
"These latest findings from the EPOS study provide valuable insights into the use of eslicarbazepine acetate in routine clinical practice. The data demonstrate the efficacy of eslicarbazepine acetate and show that it is well-tolerated as an adjunctive therapy, with high retention rates. Eslicarbazepine acetate has the added benefit of simple titration" comments Martin Holtkamp, Principal Investigator, University Hospital Charité, Germany
Additional EPOS data presented at EAN for 104 patients in Germany, reported retention rates of 86.5% and 44.7% of patients experiencing seizure freedom during the last three months of the study period. With the study investigators concluding that eslicarbazepine acetate as add-on to antiepileptic monotherapy is well-tolerated with high retention by the majority of adult patients in a real-life German population. [5]
The continued development of eslicarbazepine acetate underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eslicarbazepine acetate is already available in Albania*, Austria, Czech Republic, Cyprus*, Denmark, Finland, France, Germany (co-promotion with BIAL, the developer of eslicarbazepine acetate), Greece, Iceland, Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden, Spain (co-promotion with BIAL), UK (co-promotion with BIAL) and the U.S**.
*Exclusively by BIAL
**Eslicarbazepine acetate is sold in the U.S. under the trade name APTIOM®
Notes to Editors
About Zebinix® (eslicarbazepine acetate)
Eslicarbazepine acetate is a voltage-gated sodium channel blocker.[6] The molecule interacts competitively with the inactive state of the sodium ion channel[6],[7] preventing its return to the active state, and thereby inhibiting repetitive neuronal firing.[3],[6]The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept Phase II study[8] and four subsequent Phase III randomised, placebo controlled studies in 1,703 adult patients with partial onset seizures refractory to treatment with one to three concomitant anti-epileptic drugs.[3],[9],[10],[11],[12],[13]
Zebinix® is the EU trade name for eslicarbazepine acetate
Zebinix® is under license from BIAL
Exalief® is the trade name for eslicarbazepine acetate in the Russian Federation.
For further information please visit: http://www.eisai.co.uk
About Epilepsy
Epilepsy is one of the most common neurological conditions in the world, affecting approximately 6 million people in Europe, and an estimated 50 million people worldwide.[14],[15] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
About Eisai EMEA in Epilepsy
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
About Eisai Co Ltd
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit http://www.eisai.com.
About BIAL
Founded in 1924, BIAL's mission is to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has focused on quality, innovation and internationalization. It is the partner of choice for many companies, having a strong presence in the Iberian Peninsula as well as in over 10 countries in Latin America and in several French- or Portuguese-speaking African countries.
BIAL is strongly committed to therapeutic innovation, investing more than 20% of its turnover in research and development (R&D) every year, placing it among the most innovative European companies. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy.
BIAL's innovative programmes focus on continuing the clinical development of its anti-epileptic Zebinix/Aptiom (on the market in Europe and the USA), as well as opicapone for Parkinson's disease.
With a team of 900 employees, BIAL has reinforced its international presence, an aspect that the company will strengthen over the next decade.
Further information about BIAL can be found at http://www.bial.com
References
1. Holtkamp M et al. Eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in adults with partial-onset seizures: real-world data from the EPOS study. EAN 2015 abstract 758
2. Kwan P, Brodie MJ. Early identification of refractory epilepsy. New England Journal of Medicine 2000:342:314-9
3. Zebinix , Summary of Product Characteristics (updated September 2014): http://www.medicines.org.uk/emc/medicine/22376/
4. Lawthom C et al. Effectiveness of eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in adults with partial-onset seizures (EPOS study): analysis by baseline antiepileptic drug. EAN 2015 abstract #765
5. Losch F et al. Eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in adults with partial-onset seizures: German data of the EPOS study. EAN 2015 abstract #976
6. Almeida L, Soares-da-Silva P.Eslicarbazepine Acetate (BIA 2-093). Neurotherapeutics. 2007:4(1):88-96
7. Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers.Epilepsia 2013:54(8):1453-1461
8. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on, Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset Seizures. Epilepsia 2007:48(3):497-504
9. Elger C et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia 2009:50(3):454-463
10. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010:89:278-285
11. Gil-Nagel A et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand 2009:120: 281-287
12. Sperling M et al. Adjunctive Eslicarbazepine acetate in patients with seizures: efficacy result s of a 12 week randomized placebo-controlled study. Abstract presented at AES 2013. #3.210
13. Abou-Khalil B et al. Eslicarbazepine acetate as adjunctive therapy in patients with refractory partial-onset seizures: safety results of a 12-week randomized placebo-controlled study. Abstract presented at AES 2013. #2.128
14. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (accessed June 2014)
15. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-2233.
Date of preparation: June 2015
Job code: Zebinix-UK2333
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