强生的抑郁症药物Spravato鼻喷雾剂,在欧洲获批

2019-12-21 不详 MedSci原创

强生的抑郁症药物Spravato(esketamine)鼻喷雾剂,已在欧洲被批准用于治疗患有抗药性重度抑郁症的成年人。欧盟委员会(EC)批准该药物与选择性5-羟色胺再摄取抑制剂(SSRI)或5-羟色胺和去甲肾上腺素再摄取抑制剂(SNRI)结合使用,用于对至少两种抗抑郁药没有反应的成年患者。

强生的抑郁症药物Spravato(esketamine)鼻喷雾剂,已在欧洲被批准用于治疗患有抗药性重度抑郁症的成年人。欧盟委员会(EC)批准该药物与选择性5-羟色胺再摄取抑制剂(SSRI)或5-羟色胺和去甲肾上腺素再摄取抑制剂(SNRI)结合使用,用于对至少两种抗抑郁药没有反应的成年患者。

该委员会表示,该授权的依据是针对患有抗药性抑郁症的患者(包括1600多例使用Spravato鼻喷雾剂治疗的患者)进行的强有力的临床试验数据。

一项试验发现,大约70%的治疗患者对治疗有反应,症状减轻≥50%。此外,在为期四周的研究结束时,大约有一半的Spravato鼻喷剂治疗的患者实现了缓解。

此外在维持治疗期间,与仅口服抗抑郁药相比,Spravato鼻喷剂持续治疗在具有稳定反应患者中将复发风险降低了70%,在稳定缓解患者中降低了51%。

该决定还遵循了EMA人用药用产品委员会(CHMP)在2019年10月18日提出的积极意见。

整个欧洲,大约有4000万人患有重度抑郁症,仅在英格兰,就有180万人受此困扰。患有MDD的人在被诊断之前可能会遭受数月甚至数年的发作,其影响超出了精神病和身体症状,并且还可能影响就业、教育、健康和整体生活质量。

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    2020-04-10 俅侠
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    2020-05-29 sodoo
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