{"id":3435,"date":"2018-05-31T00:00:00","date_gmt":"2021-03-19T01:34:51","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=3435"},"modified":"2021-03-19T09:34:51","modified_gmt":"2021-03-19T01:34:51","slug":"%e5%8d%ab%e6%9d%90%e6%8a%97%e7%99%ab%e7%97%ab%e8%8d%affycompa%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e5%84%bf%e7%ab%a5%e7%99%ab%e7%97%ab%e6%82%a3%e8%80%85%e7%9a%84%e6%96%b0%e8%8d%af%e8%a1%a5%e5%85%85","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/2018\/05\/31\/%e5%8d%ab%e6%9d%90%e6%8a%97%e7%99%ab%e7%97%ab%e8%8d%affycompa%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e5%84%bf%e7%ab%a5%e7%99%ab%e7%97%ab%e6%82%a3%e8%80%85%e7%9a%84%e6%96%b0%e8%8d%af%e8%a1%a5%e5%85%85\/","title":{"rendered":"\u536b\u6750\u6297\u766b\u75eb\u836fFYCOMPA\u7528\u4e8e\u6cbb\u7597\u513f\u7ae5\u766b\u75eb\u60a3\u8005\u7684\u65b0\u836f\u8865\u5145\u7533\u8bf7\u88ab\u7f8e\u56fd\u98df\u836f\u76d1\u5c40\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4"},"content":{"rendered":"<p style=\"font-weight: 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style=\"font-weight: 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style=\"font-weight: 400;\">\u7f8e\u56fd\u5927\u7ea6\u6709290\u4e07\u766b\u75eb\u60a3\u8005\uff0c\u65e5\u672c\u7ea6\u6709100\u4e07\uff0c\u6b27\u6d32\u7ea6\u6709600\u4e07\uff0c\u800c\u5168\u4e16\u754c\u7ea6\u67096000\u4e07\u766b\u75eb\u60a3\u8005\u3002\u766b\u75eb\u5728\u5404\u5e74\u9f84\u6bb5\u7686\u6709\u53d1\u751f\uff0c\u5728\u8001\u4eba\u548c\u513f\u7ae5\u4e2d\u5c24\u5176\u9ad8\u53d1\u3002\u5927\u7ea630%\u7684\u766b\u75eb\u60a3\u8005\u4f7f\u7528\u73b0\u6709\u7684\u6297\u766b\u75eb\u836f\u7269\u4e0d\u80fd\u63a7\u5236\u766b\u75eb\u53d1\u4f5c<sup>1<\/sup>\u3002\u56e0\u6b64\uff0c\u766b\u75eb\u4ecd\u662f\u4e00\u79cd\u533b\u7597\u9700\u6c42\u660e\u663e\u672a\u88ab\u6ee1\u8db3\u7684\u75be\u75c5\u3002<\/p>\n<p style=\"font-weight: 400;\">\u536b\u6750\u5c06\u5305\u62ec\u766b\u75eb\u5728\u5185\u7684\u795e\u7ecf\u9886\u57df\u4f5c\u4e3a\u91cd\u70b9\u6cbb\u7597\u9886\u57df\uff0c\u5e76\u81f4\u529b\u4e8e\u5c06Fycompa\u63a8\u5e7f\u5230\u4e16\u754c\u5404\u5730\uff0c\u4f7f\u66f4\u591a\u9971\u53d7\u766b\u75eb\u6298\u78e8\u7684\u60a3\u8005\u6446\u8131\u766b\u75eb\u53d1\u4f5c\u3002\u536b\u6750\u81f4\u529b\u4e8e\u4e3a\u6ee1\u8db3\u766b\u75eb\u60a3\u8005\u53ca\u5176\u5bb6\u5c5e\u7684\u591a\u6837\u5316\u9700\u6c42\uff0c\u5e76\u63d0\u9ad8\u4ed6\u4eec\u7684\u798f\u7949\uff0c\u800c\u4f5c\u51fa\u66f4\u5927\u7684\u8d21\u732e\u3002<\/p>\n<p style=\"font-weight: 400;\">\n<b><strong style=\"font-style: inherit;\">\u5a92\u4f53\u54a8\u8be2\uff1a<\/strong><\/b><br \/>\n\u536b\u6750\u682a\u5f0f\u4f1a\u793e<br \/>\n\u516c\u5171\u5173\u7cfb\u90e8<br \/>\n+81-(0)3-3817-5120\n<\/p>\n<p><strong>[<\/strong><strong>\u7f16\u8005\u6309]<br \/>\nAbout Study 311<br \/>\n<\/strong>Study 311 is a global (United States, Europe, Japan, Asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of Fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.<br \/>\nFollowing the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of Fycompa orally once-daily, long term safety was assessed during an extension phase. In Japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of Fycompa orally once-daily. The adverse events (\u226510% in the perampanel arms) observed in Study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.<\/p>\n<p><strong>About Study 232<br \/>\n<\/strong>Study 232 was a global (United States, Europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). The study evaluated the pharmacokinetics, safety, tolerability and efficacy of Fycompa oral suspension taken at the same time as other AEDs. Administration of once-daily Fycompa was titrated from 0.015 mg\/kg to 0.18 mg\/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). The most common adverse events (\u226510% in the perampanel arms) observed in Study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.<\/p>\n<ol>\n<li style=\"font-weight: 400;\">&#8220;The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?&#8221; National Institute of Neurological Disorders and Stroke, accessed May 24, 2016,<a href=\"http:\/\/www.ninds.nih.gov\/disorders\/epilepsy\/detail_epilepsy.htm#230253109\">http:\/\/www.ninds.nih.gov\/disorders\/epilepsy\/detail_epilepsy.htm#230253109<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>\u536b\u6750\u682a\u5f0f\u4f1a\u793e\uff08\u603b\u90e8\u4f4d\u4e8e\u65e5\u672c\u4e1c\u4eac\uff0c\u73b0\u4efb\u793e\u957f\u4e3a\u5185\u85e4\u6674\u592b\uff0c\u4ee5\u4e0b\u7b80\u79f0&#8221;\u536b\u6750&#8221;\uff09\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u836f\u76d1\u5c40\uff08FDA\uff09\u5df2\u63a5\u53d7\u536b\u6750\u6297\u766b\u75eb\u836f\u00a0Fycompa\uff08\u5421\u4ed1\u5e15\u5948\uff09\u7684\u8865\u5145\u65b0\u836f\u7533\u8bf7\uff0c\u5e76\u8fdb\u884c\u5ba1\u8bc4\u3002\u8be5\u7533\u8bf7\u65e8\u5728\u83b7\u51c6\u6269\u5927\u8be5\u836f\u7684\u9002\u7528\u8303\u56f4\uff0c\u8986\u76d6\u766b\u75eb\u90e8\u5206\u6027\u53d1\u4f5c\u548c\u539f\u53d1\u6027\u5168\u9762\u6027\u5f3a\u76f4\u9635\u631b\u53d1\u4f5c\u7684\u513f\u7ae5\u60a3\u8005\u3002\u6b64\u5916\uff0c\u6309FDA\u7684\u8981\u6c42\uff0c\u536b\u6750\u8fd8\u5728\u300a\u513f\u7ae5\u7528\u836f\u4e66\u9762\u7533\u8bf7\u300b\u4e2d\u63d0\u4f9b\u4e86\u9488\u5bf9\u8be5\u6297\u766b\u75eb\u65b0\u836f\u8fdb\u884c\u7684\u8bd5\u9a8c\u7814\u7a76\u3002\u56e0\u6b64\uff0cFDA\u5df2\u5bf9\u8be5\u7533\u8bf7\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\uff0c\u8fd9\u610f\u5473\u7740\uff0c\u5ba1\u8bc4\u671f\u4ec5\u4e3a6\u4e2a\u6708\u3002\u57fa\u4e8e\u300a\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA\uff09\u300b\uff0cFDA\u5ba1\u67e5\u7ec8\u4e86\u76ee\u6807\u65e5\u4e3a2018\u5e749\u670828\u65e5\u3002<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[],"class_list":["post-3435","post","type-post","status-publish","format-standard","hentry","category-news-zh"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/3435"}],"collection":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=3435"}],"version-history":[{"count":2,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/3435\/revisions"}],"predecessor-version":[{"id":3437,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/3435\/revisions\/3437"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=3435"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=3435"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=3435"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}