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Alkermes的精神分裂症候选药物ALKS 3831将扩大向FDA的营销申请，以用于治疗I型双相情感障碍

2019-07-16 不详 MedSci原创

Alkermes精神分裂症ALKS3831FDA营销申请I型双相情感障碍
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Alkermes周一表示，在与FDA会面后，该制药商计划扩大其ALKS 3831在美国的营销申请，将ALKS 3831与非典型抗精神病药奥氮平和阿片类拮抗剂samidorphan联合治疗I型双相情感障碍和精神分裂症，是一种每日一次的口服药物。Alkermes预计将在第四季度提交申请文件，将包括ALKS 3831治疗精神分裂症患者的ENLIGHTEN临床结果，以及比较ALKS 3831和Eli Li

Alkermes周一表示，在与FDA会面后，该制药商计划扩大其ALKS 3831在美国的营销申请，将ALKS 3831与非典型抗精神病药奥氮平和阿片类拮抗剂samidorphan联合治疗I型双相情感障碍和精神分裂症。该药物是一种每日一次的口服药物。Alkermes预计将在第四季度提交申请文件，文件将包括ALKS 3831治疗精神分裂症患者的ENLIGHTEN临床结果，以及比较ALKS 3831和Eli Lilly的Zyprexa（奥氮平）的药代动力学桥接数据。

Alkermes指出，除了精神分裂症外，新药申请还将包括支持躁狂或混合发作适应症的数据，作为单药治疗或作为锂或丙戊酸钠的辅助治疗，以及I型双相情感障碍的维持治疗。

ENLIGHTEN-2研究的III期结果证明该疗法在稳定精神分裂症患者中与安慰剂相比，在保持体重增加副作用方面明显更好。同时来自精神分裂症急性加重患者的晚期ENLIGHTEN-1试验数据显示，ALKS 3831已达到预定的主要终点。

Alkermes首席医疗官Craig Hopkinson评论说："我们很高兴与FDA达成协议，根据药代动力学桥接数据ENLIGHTEN精神分裂症计划的结果，将对ALKS 3831治疗I型双相障碍的监管审查途径进行调整。"

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    2019-09-15 yuanming7

    #候选药物#

    0

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    2019-10-09 1179102698_36768933

    #ALKS#

    0

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    2019-07-18 wodejia-dayu

    #双相情感障碍#

    0

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    2019-07-18 heli0118

    #精神分裂#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2052413, encodeId=c56d205241300, content=<a href='/topic/show?id=688a2e469f0' target=_blank style='color:#2F92EE;'>#候选药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=27469, encryptionId=688a2e469f0, topicName=候选药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=467c360, createdName=yuanming7, createdTime=Sun Sep 15 01:43:00 CST 2019, time=2019-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1636430, encodeId=0fe71636430bd, content=<a href='/topic/show?id=9f1523180a' target=_blank style='color:#2F92EE;'>#ALKS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2318, encryptionId=9f1523180a, topicName=ALKS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2b1122641324, createdName=1179102698_36768933, createdTime=Wed Oct 09 08:43:00 CST 2019, time=2019-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301796, encodeId=83a21301e9634, content=<a href='/topic/show?id=c34e3e53295' target=_blank style='color:#2F92EE;'>#双相情感障碍#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37532, encryptionId=c34e3e53295, topicName=双相情感障碍)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7ca4300, createdName=wodejia-dayu, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1404115, encodeId=29ac14041153c, content=<a href='/topic/show?id=7366e6493be' target=_blank style='color:#2F92EE;'>#精神分裂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76493, encryptionId=7366e6493be, topicName=精神分裂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568728, encodeId=d3731568e28b4, content=<a href='/topic/show?id=8b7d53129cc' target=_blank style='color:#2F92EE;'>#情感障碍#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53129, encryptionId=8b7d53129cc, topicName=情感障碍)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=afcb15435989, createdName=天堂的云, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590807, encodeId=08f7159080ee3, content=<a href='/topic/show?id=0c0b115e4cf' target=_blank style='color:#2F92EE;'>#MES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11574, encryptionId=0c0b115e4cf, topicName=MES)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=874617863969, createdName=longqijun254, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=369781, encodeId=f07d369e814f, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=afa32365525, createdName=122e052cm96暂无昵称, createdTime=Tue Jul 16 17:24:16 CST 2019, time=2019-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=369780, encodeId=0690369e807a, content=666, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/01/04/2540fb84decb81d47a7f2868070e6cbd.jpg, createdBy=ed3f2205793, createdName=百草, createdTime=Tue Jul 16 17:04:32 CST 2019, time=2019-07-16, status=1, ipAttribution=)]
    2019-07-18 天堂的云

    #情感障碍#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2052413, encodeId=c56d205241300, content=<a href='/topic/show?id=688a2e469f0' target=_blank style='color:#2F92EE;'>#候选药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=27469, encryptionId=688a2e469f0, topicName=候选药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=467c360, createdName=yuanming7, createdTime=Sun Sep 15 01:43:00 CST 2019, time=2019-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1636430, encodeId=0fe71636430bd, content=<a href='/topic/show?id=9f1523180a' target=_blank style='color:#2F92EE;'>#ALKS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2318, encryptionId=9f1523180a, topicName=ALKS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2b1122641324, createdName=1179102698_36768933, createdTime=Wed Oct 09 08:43:00 CST 2019, time=2019-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301796, encodeId=83a21301e9634, content=<a href='/topic/show?id=c34e3e53295' target=_blank style='color:#2F92EE;'>#双相情感障碍#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37532, encryptionId=c34e3e53295, topicName=双相情感障碍)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7ca4300, createdName=wodejia-dayu, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1404115, encodeId=29ac14041153c, content=<a href='/topic/show?id=7366e6493be' target=_blank style='color:#2F92EE;'>#精神分裂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76493, encryptionId=7366e6493be, topicName=精神分裂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568728, encodeId=d3731568e28b4, content=<a href='/topic/show?id=8b7d53129cc' target=_blank style='color:#2F92EE;'>#情感障碍#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53129, encryptionId=8b7d53129cc, topicName=情感障碍)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=afcb15435989, createdName=天堂的云, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590807, encodeId=08f7159080ee3, content=<a href='/topic/show?id=0c0b115e4cf' target=_blank style='color:#2F92EE;'>#MES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11574, encryptionId=0c0b115e4cf, topicName=MES)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=874617863969, createdName=longqijun254, createdTime=Thu Jul 18 07:43:00 CST 2019, time=2019-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=369781, encodeId=f07d369e814f, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=afa32365525, createdName=122e052cm96暂无昵称, createdTime=Tue Jul 16 17:24:16 CST 2019, time=2019-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=369780, encodeId=0690369e807a, content=666, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/01/04/2540fb84decb81d47a7f2868070e6cbd.jpg, createdBy=ed3f2205793, createdName=百草, createdTime=Tue Jul 16 17:04:32 CST 2019, time=2019-07-16, status=1, ipAttribution=)]
    2019-07-18 longqijun254

    #MES#

    0

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    2019-07-16 122e052cm96暂无昵称

    好

    0

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    2019-07-16 百草

    666

    0

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