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谷氨酸受体调节剂:Spravato鼻喷雾剂获得FDA咨询委员会的批准治疗耐药性抑郁症

2019-02-15 不详 MedSci原创

美国食品和药物管理局(FDA)精神药理学药物咨询委员会和药物安全与风险管理咨询委员会共同投票赞成Spravato(艾氯胺酮)鼻喷雾剂CIII用于治疗耐药性抑郁症的成年患者。

美国食品和药物管理局(FDA)精神药理学药物咨询委员会和药物安全与风险管理咨询委员会共同投票赞成Spravato(艾氯胺酮)鼻喷雾剂CIII用于治疗耐药性抑郁症的成年患者。

Spravato是一种谷氨酸受体调节剂,开发用于恢复重度抑郁症患者脑细胞的突触连接。

此次批准是基于治疗耐药性抑郁症患者的五项III期研究的安全性和有效性数据:三项短期研究,一个维持药效研究和一项长期安全性研究。

该试验表明,Spravato鼻喷雾剂联合新开发的口服抗抑郁药,在耐药性抑郁症患者人群中展现出快速且持续性的抑郁症状改善。

该药物制造商Janssen去年9月向FDA提交新药申请(NDA)以获得Spravato的批准。一旦获批,该药物将成为30年来首个调控新机制来治疗耐药性抑郁症的药物。

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    2019-09-16 sodoo
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    2019-02-20 俅侠
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