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FDA以安全性问题和缺乏数据为由拒绝Nektar的阿片类镇痛药NKTR-181

2020-01-15 Allan MedSci原创

阿片类镇痛药NKTR-181Nektar
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FDA顾问小组星期二以27比0投票反对Nektar Therapeutics的阿片类镇痛药NKTR-181（也称为oxycodegol）的批准。

FDA顾问小组星期二以27比0投票反对Nektar Therapeutics的阿片类镇痛药NKTR-181（也称为oxycodegol）的批准。作为对投票结果的回应，Nektar表示已决定撤回营销申请，该申请旨在寻求批准NKTR-181治疗成年人的慢性腰背痛，其疼痛严重到需要每天服用镇痛药物。在FDA会议上，咨询委员会提到了有关药物滥用以及肝毒性的担忧。专家组成员Lee Hoffer评论说：“由于缺乏数据，我们不能确定收益是否大于风险”。

阿片类药物（Opioid）是具有吗啡作用的化学物质，主要用途是镇痛。阿片类药物通过存在于中枢神经系统和消化系统的阿片类受体（Opioid receptor）起作用。这些阿片类受体能引发有益的药物作用或药物不良反应。


原始出处：

https://www.firstwordpharma.com/node/1693821

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1751738, encodeId=2ce51e5173813, content=<a href='/topic/show?id=ba8612842b3' target=_blank style='color:#2F92EE;'>#NKT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12842, encryptionId=ba8612842b3, topicName=NKT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74e936405699, createdName=xuruicheng, createdTime=Fri Nov 06 12:27:00 CST 2020, time=2020-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675253, encodeId=f94c16e5253d6, content=<a href='/topic/show?id=04a412633ea' target=_blank style='color:#2F92EE;'>#Nektar#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12633, encryptionId=04a412633ea, topicName=Nektar)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cd0827209070, createdName=雕雕, createdTime=Fri Jul 03 03:27:00 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1309147, encodeId=0b50130914e38, 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=38, 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=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355334, encodeId=06ab13553346e, content=<a href='/topic/show?id=256a96e9990' target=_blank style='color:#2F92EE;'>#镇痛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96799, encryptionId=256a96e9990, topicName=镇痛)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472056, encodeId=cc8814e205683, content=<a href='/topic/show?id=61279e89844' target=_blank style='color:#2F92EE;'>#阿片类镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97898, encryptionId=61279e89844, topicName=阿片类镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f7e57200072, createdName=w984447tii, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579738, encodeId=337715e9738c9, content=<a href='/topic/show?id=567c96806cc' target=_blank style='color:#2F92EE;'>#镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96806, encryptionId=567c96806cc, topicName=镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef4d16558274, createdName=ms9476844295372110, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631038, encodeId=18d81631038d4, content=<a href='/topic/show?id=f571128452a' target=_blank style='color:#2F92EE;'>#NKTR-181#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12845, encryptionId=f571128452a, topicName=NKTR-181)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=854b21658779, createdName=chenzhuanggui, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=)]
    2020-11-06 xuruicheng

    #NKT#

    0

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    2020-07-03 雕雕

    #Nektar#

    0

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    2020-01-17 lhlxtx

    #阿片类#

    0

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    2020-01-17 zhaojie88

    #镇痛#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1751738, encodeId=2ce51e5173813, content=<a href='/topic/show?id=ba8612842b3' target=_blank style='color:#2F92EE;'>#NKT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12842, encryptionId=ba8612842b3, topicName=NKT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74e936405699, createdName=xuruicheng, createdTime=Fri Nov 06 12:27:00 CST 2020, time=2020-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675253, encodeId=f94c16e5253d6, content=<a href='/topic/show?id=04a412633ea' target=_blank style='color:#2F92EE;'>#Nektar#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12633, encryptionId=04a412633ea, topicName=Nektar)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cd0827209070, createdName=雕雕, createdTime=Fri Jul 03 03:27:00 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1309147, encodeId=0b50130914e38, 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=38, 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=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355334, encodeId=06ab13553346e, content=<a href='/topic/show?id=256a96e9990' target=_blank style='color:#2F92EE;'>#镇痛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96799, encryptionId=256a96e9990, topicName=镇痛)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472056, encodeId=cc8814e205683, content=<a href='/topic/show?id=61279e89844' target=_blank style='color:#2F92EE;'>#阿片类镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97898, encryptionId=61279e89844, topicName=阿片类镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f7e57200072, createdName=w984447tii, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579738, encodeId=337715e9738c9, content=<a href='/topic/show?id=567c96806cc' target=_blank style='color:#2F92EE;'>#镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96806, encryptionId=567c96806cc, topicName=镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef4d16558274, createdName=ms9476844295372110, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631038, encodeId=18d81631038d4, content=<a href='/topic/show?id=f571128452a' target=_blank style='color:#2F92EE;'>#NKTR-181#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12845, encryptionId=f571128452a, topicName=NKTR-181)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=854b21658779, createdName=chenzhuanggui, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=)]
    2020-01-17 w984447tii

    #阿片类镇痛药#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1751738, encodeId=2ce51e5173813, content=<a href='/topic/show?id=ba8612842b3' target=_blank style='color:#2F92EE;'>#NKT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12842, encryptionId=ba8612842b3, topicName=NKT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74e936405699, createdName=xuruicheng, createdTime=Fri Nov 06 12:27:00 CST 2020, time=2020-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675253, encodeId=f94c16e5253d6, content=<a href='/topic/show?id=04a412633ea' target=_blank style='color:#2F92EE;'>#Nektar#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12633, encryptionId=04a412633ea, topicName=Nektar)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cd0827209070, createdName=雕雕, createdTime=Fri Jul 03 03:27:00 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1309147, encodeId=0b50130914e38, 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=38, 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=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355334, encodeId=06ab13553346e, content=<a href='/topic/show?id=256a96e9990' target=_blank style='color:#2F92EE;'>#镇痛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96799, encryptionId=256a96e9990, topicName=镇痛)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472056, encodeId=cc8814e205683, content=<a href='/topic/show?id=61279e89844' target=_blank style='color:#2F92EE;'>#阿片类镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97898, encryptionId=61279e89844, topicName=阿片类镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f7e57200072, createdName=w984447tii, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579738, encodeId=337715e9738c9, content=<a href='/topic/show?id=567c96806cc' target=_blank style='color:#2F92EE;'>#镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96806, encryptionId=567c96806cc, topicName=镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef4d16558274, createdName=ms9476844295372110, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631038, encodeId=18d81631038d4, content=<a href='/topic/show?id=f571128452a' target=_blank style='color:#2F92EE;'>#NKTR-181#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12845, encryptionId=f571128452a, topicName=NKTR-181)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=854b21658779, createdName=chenzhuanggui, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=)]
    2020-01-17 ms9476844295372110

    #镇痛药#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1751738, encodeId=2ce51e5173813, content=<a href='/topic/show?id=ba8612842b3' target=_blank style='color:#2F92EE;'>#NKT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12842, encryptionId=ba8612842b3, topicName=NKT)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74e936405699, createdName=xuruicheng, createdTime=Fri Nov 06 12:27:00 CST 2020, time=2020-11-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675253, encodeId=f94c16e5253d6, content=<a href='/topic/show?id=04a412633ea' target=_blank style='color:#2F92EE;'>#Nektar#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12633, encryptionId=04a412633ea, topicName=Nektar)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cd0827209070, createdName=雕雕, createdTime=Fri Jul 03 03:27:00 CST 2020, time=2020-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1309147, encodeId=0b50130914e38, 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=38, 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=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1355334, encodeId=06ab13553346e, content=<a href='/topic/show?id=256a96e9990' target=_blank style='color:#2F92EE;'>#镇痛#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96799, encryptionId=256a96e9990, topicName=镇痛)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472056, encodeId=cc8814e205683, content=<a href='/topic/show?id=61279e89844' target=_blank style='color:#2F92EE;'>#阿片类镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97898, encryptionId=61279e89844, topicName=阿片类镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f7e57200072, createdName=w984447tii, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579738, encodeId=337715e9738c9, content=<a href='/topic/show?id=567c96806cc' target=_blank style='color:#2F92EE;'>#镇痛药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96806, encryptionId=567c96806cc, topicName=镇痛药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef4d16558274, createdName=ms9476844295372110, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631038, encodeId=18d81631038d4, content=<a href='/topic/show?id=f571128452a' target=_blank style='color:#2F92EE;'>#NKTR-181#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12845, encryptionId=f571128452a, topicName=NKTR-181)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=854b21658779, createdName=chenzhuanggui, createdTime=Fri Jan 17 09:27:00 CST 2020, time=2020-01-17, status=1, ipAttribution=)]
    2020-01-17 chenzhuanggui

    #NKTR-181#

    0