药品名称：醋酸艾司利卡西平

英文药名：Zebinix（eslicarbazepine acetate）

剂    型：片剂

规    格：400mg；600mg；800mg；

适 应 症：用于癫痫局部性发作，伴有或不伴有继发性全身发作的成年癫痫患者的辅助治疗。

化学结构式：

药理作用及作用机制：

醋酸艾司利卡西平是为提高卡马西平(CBZ) 和奥卡西平(OXC)的疗效、改善其耐受性而开发的抗癫痫新药，为CBZ类第3代药物S -利卡西平的前药、OXC的活性代谢物。它是一种新型的钠离子通道阻滞剂，特异性的作用于离子通道，阻止其返回活性状态从而降低其反复活化频率。适应症是用于治疗最常见的部分发作性癫痫。由于卡马西平在治疗过程中容易产生毒性代谢产物而导致出现严重的副作用，而奥卡西平虽能降低副作用的严重性，但药物疗效却明显降低。相对而言，醋酸艾司利卡西平能够有效治疗各种病症如癫痫和情感性脑功能障碍，以及退行性和缺血后疾病中的疼痛和神经功能交替；同时治疗过程中代谢的毒性代谢物较低，而药物疗效也不会降低。

醋酸艾司利卡西平片系葡萄牙Bial 制药公司开发上市的主要用于治疗癫痫的药物，已于2009年在欧洲批准上市销售，商品名为名Zebinix和Exalief。其在美国和加拿大的上市前临床研究正在进行中。

醋酸艾司利卡西平为一种新型抗癫痫药，通过调节钠通道活动来产生治疗作用，一天一次不仅显著降低难控性癫痫部分性发作患者的发作频率，还可提高患者生活质量降低抑郁症状。

临床结果显示抗痫药Zebinix显著降低发病频率

一项延展性III期临床实验结果显示，Zebinix(eslicarbazepine acetate)作为辅助药物治疗癫痫症患者后，他们的发病频率显著降低，并且疗效能长期保持。
实验数据显示，那些未使用过现有抗痫药物治疗的患者以Zebinix作为辅助药物治疗之后，他们的发病频率平均降低了61%，该药仅需每日使用一次。
此外，该药的安全性和疗效均在实验中得到了证实，它的面世为癫痫症患者提供了一种全新有效的治疗选择。

Zebinix (TM), a New Antiepileptic Drug, Related to Tegretol, is Recommended for Approval in Europe
Eslicarbazepine, brand name Zebinix™, is a new epilepsy drug, related to carbamazepine (Tegretol™) and oxcarbazepine (Trileptal™). Discovered in 1996, it may have fewer drug interactions than do carbamazepine and oxcarbazepine. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA, the European equivalent of the FDA) has just recommended marketing approval of Zebinix for add-on therapy in adults with partial-onset seizures, with or without secondary generalization. Among people whose seizures previously were uncontrolled, seizures were reduced in clinical trials on average by more than a third. Side effects in the trials seemed relatively minimal. The drug was developed by Bial-Portela & Ca, S.A., a Portuguese pharmaceutical company. Two other companies, Sepracor, Inc. and Eisai, will cooperate in commercialization of Zebinix™ in various parts of the world.
Novel Anti-epileptic ZEBINIX® Approved In The European Union - New Option For Treatment Of Patients With Partial-Onset Seizures
Eisai Europe Limited (Headquarters: Hatfield, UK, Chairman & CEO: Yutaka Tsuchiya, "Eisai Europe"), the European subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), and Bial - Portela & Ca, S.A. (Headquarters: São Mamede do Coronado, Portugal, CEO: Luís Portela, "Bial") announced today that the anti-epileptic drug, Zebinix® (eslicarbazepine acetate), for which Eisai Europe obtained rights from Bial to market in Europe, was approved by the European Commission on April 21st, as an adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation.
Zebinix® is a novel once daily anti-epileptic drug developed by Bial and it is believed to exert an antiepileptic effect by regulating the activity of sodium channels. The efficacy and safety of Zebinix® when used in combination with other anti-epileptic drugs have been shown in clinical data from three Phase III studies (multi-centre, randomized, double-blind, placebo-controlled trials) conducted in 23 countries with more than 1,000 patients with refractory partial-onset seizures. Zebinix® demonstrated significant reductions in seizure frequency and a significant increase in responder rates (≥ 50% reduction in seizure frequency) across all three Phase III studies. In addition, Zebinix® showed a sustained decrease in seizure frequency and a significant improvement in quality of life during the long-term (one-year) open label studies conducted subsequent to those Phase III studies.
Epilepsy has a high prevalence among central nervous system diseases and affects about 3.4 million people in Europe. There are many patients with epilepsy whose condition is difficult to treat with existing anti-epileptic drugs for seizure control. The impact of seizures on patients' quality of life should not be underestimated.
With the approval of Zebinix®, Eisai Europe will launch Zebinix® during FY2009 and FY2010 across Europe, under the terms of a license and co-promotion agreement signed with Bial on February 19th this year.
Eisai has been selling two other anti-epileptic drugs, Zonegran® for partial-onset seizures and Inovelon® for Lennox-Gastaut Syndrome, in Europe. Eisai will bring Zebinix®, a new treatment option, to patients with epilepsy as early as possible and make further contributions to addressing the diversified needs and improving quality of life of patients with epilepsy.
About Bial - Portela & Ca, S.A.
Founded in 1924, Bial is an international pharmaceutical group with products available in over 30 countries throughout four continents. Bial is the largest Portuguese pharmaceutical company and is based in S. Mamede do Coronado, Portugal.
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 around 20 French or Portuguese speaking African countries.
Bial is strongly committed to therapeutic innovation investing approximately 20% of its turnover in research and development every year. Key research areas for Bial are the central nervous system, the cardiovascular system and allergology. Bial currently has several other innovative programs under development, which the company expects to bring to the market within the next years, thereby strengthening its position throughout Europe.

--------------------------------------------------------
产地国家: 欧洲共同体国家
原产地英文商品名:
ZEBINIX 800mg/tab 30tabs/box
原产地英文药品名:
ESLICARBAZEPINE
中文参考商品译名:
ZEBINIX 800毫克/片 30片/盒
中文参考药品译名:
艾司利卡西平
生产厂家中文参考译名:
Bial-Industrial Farmaceutica
生产厂家英文名:
Bial-Industrial Farmaceutica