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FDA顾问小组支持AcelRx的阿片类止痛药Dsuvia

2018-10-14 MedSci MedSci原创

AcelR阿片类止痛药Dsuvia
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美国食品和药物管理局（FDA）咨询委员会于2018年10月12日建议批准AcelRx制药的Dsuvia（舒芬太尼）治疗在医学监督下的中度至重度成人急性疼痛。

美国食品和药物管理局（FDA）咨询委员会于2018年10月12日建议批准AcelRx制药的Dsuvia（舒芬太尼）治疗在医学监督下的中度至重度成人急性疼痛。Dsuvia（舒芬太尼）主要作用于阿片受体，其亲脂性约为芬太尼的两倍，更易通过血脑屏障，与血浆蛋白结合率较芬太尼高，而分布容积则较芬太尼小，虽然其血浆半衰期较芬太尼短，但由于与阿片受体的亲和力较芬太尼强，因而不仅镇痛强度更大，而且作用持续时间也更长（约为芬太尼的2倍）。

AcelRx表示，FDA的此次支持得到了两项随机安慰剂对照试验的数据支持，这些试验共涉及261名患者。在2016年的III期SAP302试验数据中，该疗法（也称为ARX-04）与受伤或创伤引起的中重度急性疼痛患者疼痛强度相比基线降低35％相关。AcelRx首席医疗官Pamela Palmer表示，“我们期待继续与FDA就此进行合作，因为我们认为Dsuvia是一种重要的非侵入性急性疼痛管理方案，有可能显著改善目前的护理标准”。预计美国监管机构将决定是否批准在11月3日之前通过Dsuvia的批准。


原始出处：

http://www.firstwordpharma.com/node/1597134#axzz5Trc0A3L7

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    2018-10-14 shanyongle

    #ACE#

    0

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    2019-03-11 维他命

    #CEL#

    0

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    2019-07-01 naiwu85

    #阿片类止痛药#

    0

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    2018-10-16 lancelotzzl

    #止痛药#

    0

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    2018-10-16 lhlxtx

    #阿片类#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1655904, encodeId=bccb1655904b3, content=<a href='/topic/show?id=2a011829d7' target=_blank style='color:#2F92EE;'>#ACE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1829, encryptionId=2a011829d7, topicName=ACE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=635024767990, createdName=shanyongle, createdTime=Sun Oct 14 13:40:00 CST 2018, time=2018-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1961198, encodeId=4bd0196119897, content=<a href='/topic/show?id=dbe6445416' target=_blank style='color:#2F92EE;'>#CEL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4454, encryptionId=dbe6445416, topicName=CEL)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Mon Mar 11 03:40:00 CST 2019, time=2019-03-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1654698, encodeId=9fea1654698fa, content=<a href='/topic/show?id=ebe99e884c4' target=_blank style='color:#2F92EE;'>#阿片类止痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97884, encryptionId=ebe99e884c4, topicName=阿片类止痛药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=297424527812, createdName=naiwu85, createdTime=Mon Jul 01 10:40:00 CST 2019, time=2019-07-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289985, encodeId=190812899859c, content=<a href='/topic/show?id=50e36316e7d' target=_blank style='color:#2F92EE;'>#止痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63167, encryptionId=50e36316e7d, topicName=止痛药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4f32220, createdName=lancelotzzl, createdTime=Tue Oct 16 01:40:00 CST 2018, time=2018-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1309110, encodeId=18aa1309110cb, content=<a href='/topic/show?id=a0179e879ac' target=_blank style='color:#2F92EE;'>#阿片类#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97879, encryptionId=a0179e879ac, topicName=阿片类)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e12358, createdName=lhlxtx, createdTime=Tue Oct 16 01:40:00 CST 2018, time=2018-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405554, encodeId=09f6140555427, content=<a href='/topic/show?id=597b631634d' target=_blank style='color:#2F92EE;'>#止痛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63163, encryptionId=597b631634d, topicName=止痛)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8da42553722, createdName=zhangxingru, createdTime=Tue Oct 16 01:40:00 CST 2018, time=2018-10-16, status=1, ipAttribution=)]
    2018-10-16 zhangxingru

    #止痛#

    0