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FDA批准过度流口水药物Xeomin

2018-07-04 MedSci MedSci原创

XeominFDA
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Merz Neuroscience的Xeomin已成为美国食品和药物管理局批准的第一个治疗过度流口水的药剂。唾液流变症(Sialorrheam)，或过度流口水，是患有帕金森病、肌萎缩性侧索硬化症(ALS)、脑瘫(CP)或中风的患者的常见症状。这种情况可能是由于难以保持口腔内的唾液，吞咽问题以及控制面部肌肉的问题。Xeomin是一种神经毒素，在III期数据的基础上被批准用于止血，显示与安慰剂相比，未



Merz Neuroscience的Xeomin已成为美国食品和药物管理局批准的第一个治疗过度流口水的药剂。

唾液流变症(Sialorrheam)，或过度流口水，是患有帕金森病、肌萎缩性侧索硬化症(ALS)、脑瘫(CP)或中风的患者的常见症状。

这种情况可能是由于难以保持口腔内的唾液，吞咽问题以及控制面部肌肉的问题。

Xeomin是一种神经毒素，在III期数据的基础上被批准用于止血，显示与安慰剂相比，未受刺激的唾液流量显着减少。

该公司指出，该治疗在耐受性方面也表现良好，安慰剂组和治疗组之间的不良事件总体发生率相似，未报告新的或意外的不良事件。

"这项批准是解决60多万患有慢性流涎的成年人未满足需求的重要里程碑，并强调了我们致力于改善那些患有运动障碍的人的生活，" Merz北美副总裁兼美国负责人Kevin O'Brien指出。

这是Xeomin的第四个神经系统适应症，已经在市场上出现成人手臂肌肉僵硬度增加，上肢痉挛，成人颈部肌张力障碍发生的头部位置异常和颈部疼痛，以及治疗接受肉毒杆菌毒素（肉毒杆菌毒素A）治疗的成人眼睑（眼睑痉挛）异常痉挛。


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    2019-01-10 wfang556

    #流口水#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1716657, encodeId=d1bd1e166573a, content=<a href='/topic/show?id=08a06529e91' target=_blank style='color:#2F92EE;'>#流口水#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65297, encryptionId=08a06529e91, topicName=流口水)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87ed32287740, createdName=wfang556, createdTime=Thu Jan 10 00:02:00 CST 2019, time=2019-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839604, encodeId=3a95183960428, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Wed Mar 27 11:02:00 CST 2019, time=2019-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=329334, encodeId=168d329334dc, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Wed Jul 04 22:27:53 CST 2018, time=2018-07-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=329326, encodeId=1818329326ee, content=了解一下.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Wed Jul 04 22:02:41 CST 2018, time=2018-07-04, status=1, ipAttribution=)]
    2019-03-27 智者为医08

    #FDA批准#

    0

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    2018-07-04 医者仁心5538

    学习了

    0

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    2018-07-04 天地飞扬

    了解一下.谢谢分享!

    0