重度抑郁症新药获FDA批准——强生的鼻喷雾剂Spravato

2020-08-04 MedSci原创 MedSci原创

该批准基于两项3期临床试验,结果显示Spravato联合标准治疗在24小时内显着且快速地减轻抑郁症状。

强生的Spravato(艾氯胺酮,esketamine)鼻喷雾剂获得美国食品和药物管理局(FDA)的批准,与口服抗抑郁药联合用于治疗具有严重自杀意念或行为的重度抑郁症(MDD)成人患者。

See the source image

图片来源:https://ahrp.org/dr-scott-gottlieb-gifted-johnson-johnson-controversial-ketamine-antidepressant-approved/

该批准基于两项3期临床试验,结果显示Spravato联合标准治疗在24小时内显着且快速地减轻抑郁症状。

在两项试验中,Spravato联合标准治疗24小时后,蒙哥马利-奥斯伯格抑郁量表(MADRS)显示(一种用于评估抑郁症状严重程度的常用工具)分别降低了15.9%和16.0%。

在两项试验中,接受Spravato联合标准治疗的患者,分别有41%和43%实现了抑郁症的临床缓解,而安慰剂组分别为34%和27%。

Spravato的安全性与先前研究一致,最常见的副作用包括头晕,镇静,血压升高,呕吐,欣快感和眩晕。

原始出处:

http://www.pharmatimes.com/news/janssens_depression_nasal_spray_spravato_bags_new_fda_approval_1346215

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    2020-09-04 俅侠
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    2021-04-19 sodoo
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    2021-06-09 bugit
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    2020-08-05 月瘦如眉

    学习

    0

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    2020-08-04 ms2000001051330459

    学习了,涨知识了!

    0

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