| <P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial"></SPAN>美国</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">于</SPAN> <SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">10</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">22</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Fycompa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">（</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">perampanel</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）片剂用于治疗年龄在</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">12</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">岁及以上</SPAN><SPAN><SPAN lang=ZH style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-fareast-language: ZH" XML:LANG="ZH">局灶性癫痫发作</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">患者。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: left; mso-line-height-alt: 0pt; mso-pagination: widow-orphan" align=left><SPAN><SPAN lang=ZH style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-fareast-language: ZH" XML:LANG="ZH"> <WBR> <WBR> <WBR> 局灶性</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">发作</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">是癫痫患者中最常见的类型。癫痫是一种脑部疾病，在患者大脑中的神经细胞有异常或过度活动。</SPAN><SPAN><SPAN lang=ZH style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-fareast-language: ZH" XML:LANG="ZH">局灶性</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">发作</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">影响到有限的或局部脑区，但能够传播到大脑其它部分。癫痫发作会引起一系列症状，包括重复肢体运动（痉挛）、异常行为，以及全身性抽搐、意识丧失。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US"><BR><SPAN style="mso-spacerun: yes"><FONT face=Arial><FONT color=#333333> <WBR> <WBR> <WBR></FONT></FONT></SPAN></SPAN> <SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">“有些癫痫患者以他们目前正在使用的治疗手段不能满意控制癫痫发作，”</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">药品评价和研究中心神经药物部门主任</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Russell Katz</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">博士指出。“因此有多种可供选择的治疗对癫痫患者十分重要。”</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: left; mso-line-height-alt: 0pt; mso-pagination: widow-orphan" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">三项临床试验的结果显示，服用</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Fycompa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">者与接受无活性成分的安慰剂者相比，癫痫控制明显改善。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-ALIGN: left; mso-line-height-alt: 0pt; mso-pagination: widow-orphan" align=left><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">在临床试验中接收</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Fycompa</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的患者报告的最常见不良反应包括：头晕、嗜睡、乏力、烦躁不安、跌跤、上呼吸道感染、体重增加、眩晕、肌肉协调性的损失（共济失调）、步态不稳、平衡障碍、焦虑、视觉模糊、口吃、乏力、激越和嗜睡。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US"><BR><FONT face=Arial><FONT color=#333333><SPAN style="mso-spacerun: yes"> <WBR> <WBR> <WBR></SPAN> Fycompa</FONT></FONT></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的标签上有一个加框警示，以提醒医师和患者关于神经精神事件的风险，包括烦躁不安、激越、愤怒、焦虑、偏执、欣快情绪；情绪激动和精神状态变化。这些事件中某些为严重的，可危及生命。少数患者中见有暴力思维或威胁行为。如果发现有非典型的情绪或行为改变，应立即告知医师。在作剂量调整过程中使用高剂量时，医护人员应密切监测患者。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US"><BR><FONT color=#333333><FONT face=Arial><SPAN style="mso-spacerun: yes"> <WBR> <WBR> <WBR></SPAN> Fycompa</FONT></FONT></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">配发时随附一份患者用药指南，具体说明其使用方法及安全性信息。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0; mso-pagination: widow-orphan" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Fycompa</SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-font-kerning: 0pt">是</SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">一种选择性非竞争性</SPAN></SPAN><SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">AMPA</SPAN></SPAN><SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">受体（离子型谷氨酸受体主要亚型</SPAN><FONT face="Times New Roman">）拮抗剂，化学合成。</FONT></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-font-kerning: 0pt">由</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">位于新泽西州的卫材美国公司生产。</SPAN></P>
<P style="MARGIN: 0cm 0cm 0pt"><SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US"> <WBR></SPAN></SPAN></P> |
