导读:perampanel一项Ⅲ期对比研究结果显示，perampanel能有效降低癫痫部分发作患者癫痫发作的频率明显降低，反应率增加，疗效明显优于对照剂，不良反应轻微，安全高效。

癫痫是一种脑部慢性疾患，是由一群脑细胞突然且通常是短暂过度放电所致的发作性运动、感觉、意识、精神、植物神经功能异常的疾病，临床症状反复发作。目前缺乏有效持续的治疗药品。

最新研究数据显示，卫材公司研发的抗癫痫新药——perampanel能有效治疗癫痫部分发作，使癫痫患者癫痫发作的频率明显降低，反应率增加，明显改善患者临床症状。

perampanel的一项Ⅲ期随机双盲安慰剂对照的平行研究中，706例患者随机接受安慰剂或perampanel3种不同剂量中的一种剂量。患者从2mg剂量开始，随后维持该剂量或者以每周2mg剂量增加至随机的4mg或8mg量。

结果显示，与安慰剂相比，perampanel治疗组癫痫发作的频率明显降低，反应率增加，特别是4mg和8mg治疗组更具统计学意义。Perampanel耐受性良好，最常见的不良事件为头昏、嗜睡和头痛。

perampanel是一只高选择的非竞争性AMPA型谷氨酸受体拮抗剂，是目前癫痫治疗方面最先进药物的代表,目前perampanel还在进行用于治疗神经性疼痛和偏头痛预防的研究。perampanel的出现，有望能为癫痫患者提供更安全有效的治疗药物，以降低癫痫发作，改善临床症状，提高患者生活质量。

EISAI ANNOUNCES POSITIVE PHASE III TRIAL RESULTS FOR PERAMPANEL IN PARTIAL EPILEPSY

Hatfield, UK, 24 August 2010 – Eisai today announced the results of a Phase III study for the investigational compound perampanel (E2007), a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered by Eisai and under development for adjunctive treatment of partial seizures in patients with epilepsy.

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates versus placebo, the primary outcome measures in the U.S. and the E.U., respectively. The findings were statistically significant in 4 mg and 8 mg doses compared to placebo. A linear trend for dose response was also statistically significant.

The global study consisted of 706 patients from 25 countries who were randomized to placebo or one of three perampanel doses. Patients started on 2 mg doses of perampanel, then remained on 2 mg or increased dosage weekly in 2 mg increments to their randomized doses of 4 mg or 8 mg. The most common adverse events reported were dizziness, somnolence and headache.

Study 306 is the first in a series of Phase III clinical trials as part of Eisai’s development program for perampanel and two more global Phase III studies for adjunctive therapy in partial seizures are underway. Eisai plans to submit the studies as part of global applications, and results are expected to be available within one year.

As previously announced, Eisai intends to submit simultaneously in the U.S. and E.U. in our Fiscal Year 2011.

About Eisai Europe in Epilepsy

Eisai is committed to making further contributions to addressing the diversified needs and improving quality of life of patients with epilepsy. Eisai has three currently marketed treatments in Europe, these are:
- Zonegran® as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation
- Zebinix® (eslicarbazepine acetate) (under license from Bial - Portela & Ca, S.A in Europe) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation
- Inovelon® for the treatment of seizures associated with Lennox-Gastaut Syndrome