| <P style="BACKGROUND: whitesmoke; MARGIN: 0cm 0cm 0pt; VERTICAL-ALIGN: top; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">6</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; 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; mso-font-kerning: 0pt" XML:LANG="EN-US">7</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; 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-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，美国</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">FDA</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">批准多动腿综合征治疗药加巴喷丁</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">恩那卡比</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">（</SPAN></SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #444444; FONT-FAMILY: Arial" XML:LANG="EN-US">gabapentin</SPAN> <SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">enacarbil</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，商品名</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Horizant</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">）缓释片新适应症：带状疱疹后神经痛，带状疱疹愈合后的一种神经性疼痛综合征。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" 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-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">加巴喷丁</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">恩那卡比</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">治疗此症</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的推荐剂量为</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">600</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">毫克，每日两次。治疗应在早上开始，连续</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">3</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">天，每次</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">600</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">毫克。肾功能受损者应调整剂量。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" 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-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">加巴喷丁</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">恩那卡比</SPAN></SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">疗效和安全性在一项为期</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">12</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">周的药效试验和两项支持研究中得到证实。这三项研究共有</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">574</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">名患者参与，所有结果均符合其主要终点目标。在这项</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">12</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">周的试验中最常见的不良反应为嗜睡和头晕，服用加巴喷丁</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">恩那卡比</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">种有</SPAN></SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">10</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">％嗜睡，</SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">17</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">％头晕。</SPAN></P>
<P style="BACKGROUND: whitesmoke; MARGIN: 0cm 0cm 0pt; VERTICAL-ALIGN: top; TEXT-INDENT: 24pt; TEXT-ALIGN: left; mso-pagination: widow-orphan; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0" align=left><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: Arial; mso-font-kerning: 0pt" XML:LANG="EN-US">Horizant</SPAN><SPAN style="FONT-SIZE: 12pt; COLOR: #333333; FONT-FAMILY: 宋体; mso-font-kerning: 0pt; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">由</SPAN><FONT size=3><SPAN><SPAN lang=ZH style="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">葛兰素史克公司</SPAN></SPAN><SPAN><SPAN style="COLOR: #222222; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">和</SPAN></SPAN><SPAN lang=EN-US style="FONT-SIZE: 12pt; COLOR: #444444; FONT-FAMILY: Arial" XML:LANG="EN-US">XenoPort</SPAN></FONT><SPAN style="FONT-SIZE: 12pt; COLOR: #444444; FONT-FAMILY: 宋体; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">生产销售。</SPAN></P> |
