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edivoxetine临床失败
发布日期: 2014-03-28
   
      礼来2月5日宣布,有关实验性抑郁症药物edivoxetine的3个III期研究(LNBM,LNBQ,LNBR)均未达到研究的主要终点。这些研究在重度抑郁症(MDD)患者中开展,将edivoxetine或安慰剂添加至一种选择性血清素再摄取抑制剂(SSRI)进行治疗8周后,与安慰剂相比,edivoxetine未能改善蒙哥马利-艾森贝格抑郁量表(MADRS)总评分。
    这些研究中,edivoxetine的安全性和耐受性与既往研究一致,研究的疗效数据不支持edivoxetine作为重度抑郁症(MDD)辅助治疗药物的监管意见书。这些研究的数据,将在2014年的科学论坛公布。
     2010年,礼来启动了edivoxetine的III期项目,评估edivoxetine作为辅助治疗药物用于MDD患者的疗效和安全性。该项目特别专注于既往经SSRI药物(包括礼来的Prozac、辉瑞的Zoloft、葛兰素史克的Paxil)治疗后,仅能获得部分缓解的重度抑郁症患者中未获满足的临床需求。这3项试验中,患者仍接受SSRI药物治疗,同时接受edivoxetine或安慰剂治疗。
礼来同时宣布,将不再推进edivoxetine的临床开发。(生物谷Bioon.com)

 

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