{"id":9015,"date":"2018-06-13T01:00:00","date_gmt":"2018-07-27T09:35:42","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e9%80%9f%e9%80%92-fda%e6%94%af%e6%8c%81%ef%bc%8c%e6%8a%91%e9%83%81%e7%97%87%e7%aa%81%e7%a0%b4%e6%80%a7%e6%96%b0%e8%8d%af%e5%b0%86%e6%8f%90%e9%80%9f%e7%a0%94%e5%8f%91\/"},"modified":"2018-07-27T17:35:43","modified_gmt":"2018-07-27T09:35:43","slug":"%e9%80%9f%e9%80%92-fda%e6%94%af%e6%8c%81%ef%bc%8c%e6%8a%91%e9%83%81%e7%97%87%e7%aa%81%e7%a0%b4%e6%80%a7%e6%96%b0%e8%8d%af%e5%b0%86%e6%8f%90%e9%80%9f%e7%a0%94%e5%8f%91","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/9015\/","title":{"rendered":"\u901f\u9012 | FDA\u652f\u6301\uff0c\u6291\u90c1\u75c7\u7a81\u7834\u6027\u65b0\u836f\u5c06\u63d0\u901f\u7814\u53d1"},"content":{"rendered":"
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\u258e\u836f\u660e<\/span><\/strong>\u5eb7\u5fb7\/\u62a5\u9053<\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/p>\n


<\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/span><\/strong><\/strong><\/p>\n

\u4eca\u65e5\uff0cSage Therapeutics\u5728\u4e0e\u7f8e\u56fdFDA\u8fdb\u884c\u7a81\u7834\u6027\u7597\u6cd5\u4f1a\u8bae\u540e\u5ba3\u5e03\uff0c\u5c06\u52a0\u901f\u5176\u65b0\u836fSAGE-217\u7684\u7814\u53d1\u8ba1\u5212<\/strong>\u3002\u8be5\u8ba1\u5212\u65e8\u5728\u652f\u6301SAGE-217\u7528\u4e8e\u6cbb\u7597\u91cd\u5ea6\u6291\u90c1\u75c7\uff08MDD\uff09\u548c\u4ea7\u540e\u6291\u90c1\u75c7\uff08PPD\uff09\u5728\u7f8e\u56fd\u7684\u83b7\u6279\u3002<\/span>
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\"\u901f\u9012<\/span><\/p>\n


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MDD\u662f\u4e00\u79cd\u5e38\u89c1\u4f46\u4e25\u91cd\u7684\u60c5\u7eea\u969c\u788d\uff0c\u60a3\u8005\u8868\u73b0\u51fa\u5904\u4e8e\u6291\u90c1\u60c5\u7eea\u6216\u5bf9\u65e5\u5e38\u6d3b\u52a8\u4e27\u5931\u4e50\u8da3\uff0c\u5e76\u4e14\u5bf9\u793e\u4ea4\u3001\u804c\u4e1a\u3001\u6559\u80b2\u6216\u5176\u4ed6\u91cd\u8981\u6d3b\u52a8\u4ea7\u751f\u969c\u788d\u3002\u636e\u4f30\u8ba1\uff0c\u7f8e\u56fd\u6bcf\u5e74\u7ea6\u67091600\u4e07\u4eba\u60a3\u6709\u6b64\u7c7b\u75be\u75c5\uff0c\u867d\u7136\u6297\u6291\u90c1\u836f\u88ab\u5e7f\u6cdb\u7528\u4e8e\u6cbb\u7597\uff0c\u4f46\u662f\u5927\u89c4\u6a21\u7684\u7814\u7a76\u5df2\u7ecf\u8bc1\u660e\u60a3\u8005\u9700\u8981\u989d\u5916\u7684\u6cbb\u7597<\/strong>\u3002\u800cPPD\u662f\u4e00\u79cd\u5e38\u89c1\u7684\u4e0e\u751f\u80b2\u76f8\u5173\u7684\u5e76\u53d1\u75c7\uff0c\u5bf9\u90e8\u5206\u5973\u6027\u7684\u5f71\u54cd\u901a\u5e38\u5728\u6000\u5b55\u540e\u4e09\u4e2a\u6708\u6216\u4ea7\u540e\u7684\u51e0\u4e2a\u6708\u5185\u5f00\u59cb\u3002\u4ea7\u540e\u6291\u90c1\u75c7\u53ef\u80fd\u5bf9\u5973\u6027\u548c\u5bb6\u5ead\u9020\u6210\u7834\u574f\u6027\u540e\u679c<\/strong>\uff0c\u5176\u4e2d\u5305\u62ec\u663e\u8457\u7684\u529f\u80fd\u969c\u788d\u3001\u60c5\u7eea\u4f4e\u843d\u548c\u5bf9\u65b0\u751f\u513f\u5931\u53bb\u5174\u8da3\uff0c\u4ee5\u53ca\u76f8\u5173\u7684\u6291\u90c1\u75c7\u72b6\u3002\u7136\u800c\uff0c\u76ee\u524d\u8fd8\u6ca1\u6709\u4e00\u79cd\u83b7\u5f97FDA\u6279\u51c6\u7684\u4ea7\u540e\u6291\u90c1\u75c7\u7597\u6cd5\uff0c\u8be5\u9886\u57df\u8fd8\u6709\u91cd\u5927\u7684\u533b\u7597\u9700\u6c42\u672a\u88ab\u6ee1\u8db3\u3002<\/span><\/p>\n


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SAGE-217\u662f\u4e0b\u4e00\u4ee3\u6b63\u5411\u522b\u6784\u8c03\u8282\u5242\uff0c\u6709\u671b\u4e3aMDD\u548cPPD\u60a3\u8005\u5e26\u6765\u6cbb\u7597\u5e0c\u671b<\/span><\/strong>\u3002\u5b83\u9488\u5bf9\u7a81\u89e6\u548c\u7a81\u89e6\u5916GABA\u53d7\u4f53\u7684\u9009\u62e9\u6027\uff0c\u4ee5\u53ca\u6bcf\u65e5\u53e3\u670d\u7ed9\u836f\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u5f81\u8fdb\u884c\u4e86\u4f18\u5316\u3002GABA\u7cfb\u7edf\u662f\u5927\u8111\u548c\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u7684\u4e3b\u8981\u6291\u5236\u4fe1\u53f7\u901a\u8def\uff0c\u5bf9\u8c03\u8282\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u529f\u80fd\u5177\u6709\u91cd\u8981\u610f\u4e49\u3002\u8be5\u836f\u7269\u4e8e\u4eca\u5e742\u6708\u83b7\u5f97FDA\u9881\u5e03\u7684<\/span>\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a<\/span><\/a>\uff0c\u6cbb\u7597MDD\u3002<\/span><\/p>\n


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Sage\u9488\u5bf9SAGE-217\u7684\u5feb\u901f\u7814\u53d1\u8ba1\u5212\u5305\u62ec\u4e00\u9879\u5728MDD\u60a3\u8005\u4e2d\u8fdb\u884c\u7684\u5355\u4e00\u989d\u5916\u5b89\u6170\u5242\u5bf9\u71673\u671f\u5173\u952e\u6027\u8bd5\u9a8c\uff0c\u4ee5\u53ca\u6b63\u5728PPD\u5973\u6027\u4e2d\u8fdb\u884c\u7684\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c\uff08\u73b0\u5728\u88ab\u6307\u5b9a\u4e3a\u5173\u952e\u6027\u8bd5\u9a8c\uff09<\/span><\/strong>\u3002\u8fd9\u4e24\u9879\u4e34\u5e8a\u8bd5\u9a8c\u90fd\u65e8\u5728\u8bc4\u4f30\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0cSAGE-217\u5076\u53d1\u6027\u7ed9\u836f\uff08episodic dosing\uff09\u6216\u77ed\u671f\u7597\u7a0b\u5bf9\u51cf\u8f7b\u6291\u90c1\u75c7\u72b6\u7684\u5f71\u54cd\u3002\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u7814\u7a76\u5c06\u8bc4\u4f30\u5076\u53d1\u6027\u6cbb\u7597\u5bf9\u65b0\u53d1\u6216\u590d\u53d1MDD\u7684\u7597\u6548\uff0c\u5e76\u63d0\u4f9b\u989d\u5916\u7684\u5b89\u5168\u6027\u6570\u636e\u3002<\/span><\/h1>\n


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\"\u901f\u9012<\/p>\n

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\u25b2<\/span><\/strong><\/span><\/strong><\/strong><\/strong>Sage Therapeutics\u7684\u5728\u7814\u4ea7\u54c1\u7ebf\uff08\u56fe\u7247\u6765\u6e90\uff1aSage Therapeutics\u5b98\u65b9\u7f51\u7ad9\uff09<\/span><\/strong><\/p>\n


<\/p>\n

Sage\u8ba1\u5212\u5728\u4eca\u5e74\u4e0b\u534a\u5e74\u542f\u52a8MDD\u7684\u5b89\u6170\u5242\u5bf9\u71673\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u6b64\u5916\uff0cSage\u9884\u8ba1\u5c06\u5728\u4eca\u5e74\u7b2c\u56db\u5b63\u5ea6\u516c\u5e03SAGE-217\u5b89\u6170\u5242\u5bf9\u7167\u5173\u952e\u8bd5\u9a8c\u7684\u6700\u65b0\u6570\u636e\u3002\u8fd9\u9879\u52a0\u901f\u5173\u952e\u8ba1\u5212\u5f97\u5230\u4e86\u53bb\u5e7412\u6708\u516c\u5e03\u7684MDD\u60a3\u8005\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c\u79ef\u6781\u7ed3\u679c\u7684\u652f\u6301\u3002<\/span><\/p>\n


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Sage\u516c\u53f8\u9996\u5e2d\u6267\u884c\u5b98Jeff Jonas\u535a\u58eb\u8868\u793a\uff1a\u201cSage\u5f88\u9ad8\u5174\u80fd\u591f\u6536\u5230FDA\u7684\u53cd\u9988\uff0c\u4e3aSAGE-217\u6cbb\u7597\u6291\u90c1\u75c7\u7684\u7814\u53d1\u63d0\u4f9b\u4e86\u4e00\u6761\u53ef\u80fd\u7684\u5f00\u521b\u6027\u9014\u5f84\u3002\u5728\u8fd9\u4e2a\u7814\u53d1\u9879\u76ee\u4e2d\uff0c\u6211\u4eec\u6b63\u5728\u63a2\u7d22\u4ec5\u97002\u5468\u7597\u7a0b<\/strong>\u5c31\u8ba9MDD\u60a3\u8005\u611f\u53d7\u826f\u597d\u7684\u53ef\u80fd\uff0c\u8fd9\u7c7b\u4f3c\u4e8e\u73b0\u5728\u4f7f\u7528\u6297\u751f\u7d20\u7684\u7597\u7a0b\uff0c\u800c\u4e0d\u662f\u957f\u671f\u7684\u6162\u6027\u6cbb\u7597\u3002\u6211\u4eec\u8ba4\u4e3a\u4e00\u79cd\u8d77\u6548\u8fc5\u901f\u3001\u7597\u6548\u663e\u8457\u7684\u836f\u7269\u4f1a\u662f\u771f\u6b63\u7684\u8303\u5f0f\u8f6c\u53d8\u3002SAGE-217\u5982\u679c\u7814\u53d1\u6210\u529f\u5e76\u83b7\u5f97\u6279\u51c6\uff0c\u53ef\u80fd\u4f1a\u6539\u5199\u5982\u4f55\u6cbb\u7597\u6570\u5343\u4e07MDD\u60a3\u8005\u7684\u6559\u79d1\u4e66<\/strong>\uff0c\u6700\u7ec8\u5c06\u6291\u90c1\u75c7\u8f6c\u53d8\u4e3a\u4e00\u79cd\u75be\u75c5\uff0c\u800c\u4e0d\u662f\u4e00\u79cd\u8eab\u4efd\u3002\u201d<\/span><\/p>\n


<\/h1>\n

\u53c2\u8003\u8d44\u6599\uff1a<\/span><\/h1>\n

[1] Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meeting<\/span><\/h1>\n

[2] \u836f\u660e\u5eb7\u5fb7 – \u91cd\u5ea6\u6291\u90c1\u75c7\u65b0\u836f\u83b7FDA\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a<\/span><\/h1>\n


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\"\u901f\u9012<\/p>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u660e\u5eb7\u5fb7 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u258e\u836f\u660e\u5eb7\u5fb7\/\u62a5\u9053 \u4eca\u65e5\uff0cSage Therapeutics\u5728\u4e0e\u7f8e\u56fdFDA\u8fdb\u884c\u7a81\u7834\u6027\u7597\u6cd5\u4f1a\u8bae\u540e\u5ba3\u5e03\uff0c\u5c06\u52a0\u901f\u5176\u65b0\u836f […]<\/p>\n","protected":false},"author":1,"featured_media":9016,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9015"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=9015"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9015\/revisions"}],"predecessor-version":[{"id":9020,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9015\/revisions\/9020"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/9016"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=9015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=9015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=9015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}