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FDA向Alkermes的实验性抗抑郁药ALKS 5461发出拒绝提交函

2018-04-03 MedSci MedSci原创

ALKS5461重度抑郁症Alkermes
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近日，Alkermes表示，FDA对其实验性药物ALKS 5461持否定态度，该药是一种每日给药一次治疗重度抑郁症以及对标准抗抑郁药反应不足的患者的口服疗法。根据Alkermes的说法，FDA这项决定的理由为“对所提出适应症的总体有效性证据不足”，并且在重新提交之前，Alkermes需要进一步开展ALKS 5461的临床试验。

近日，Alkermes表示，FDA对其实验性药物ALKS 5461持否定态度，该药是一种每日给药一次治疗重度抑郁症以及对标准抗抑郁药反应不足的患者的口服疗法。根据Alkermes的说法，FDA这项决定的理由为“对所提出适应症的总体有效性证据不足”，并且在重新提交之前，Alkermes需要进一步开展ALKS 5461的临床试验。

Alkermes表示，它对FDA的决定“强烈反对”，并补充道，该公司还将进一步说明监管机构所要求的信息。Alkermes首席执行官理查德波普斯说：“我们对这一决定感到非常失望，并且对美国患有严重抑郁症的患者产生了影响。”他补充说：“我们坚信临床试验所得到的结果，包括超过1500名严重抑郁症患者的数据，这些结果证明了ALKS 5461具有显著的抗抑郁活性和良好的益处-风险特征”。该公司表示，丁丙诺啡和samidorphan的固定剂量组合ALKS 5461，代表了一种新的作用机制，可用于对标准抗抑郁药治疗无效的患者。

抑郁症又称抑郁障碍，以显著而持久的心境低落为主要临床特征，是心境障碍的主要类型。临床可见心境低落与其处境不相称，情绪的消沉可以从闷闷不乐到悲痛欲绝，自卑抑郁，甚至悲观厌世，可有自杀企图或行为；甚至发生木僵；部分病例有明显的焦虑和运动性激越；严重者可出现幻觉、妄想等精神病性症状。每次发作持续至少2周以上、长者甚或数年，多数病例有反复发作的倾向，每次发作大多数可以缓解，部分可有残留症状或转为慢性。


原始出处：

http://www.firstwordpharma.com/node/1553298#axzz5BZmS3b4V

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    2018-10-25 1179102698_36768933

    #ALKS#

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    2018-05-24 wetgdt

    #抑郁药#

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    2018-04-19 lujian

    #实验性#

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    2018-04-05 wushaoling

    #抗抑郁#

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    2018-04-05 longqijun254

    #MES#

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