In March, 2019, the US Food and Drug Administration (FDA) approved two new antidepressants: esketamine for treatment-resistant depression and brexanolone for postpartum depression. Both had the breakthrough designation, an expedited review process for drugs “intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)”. Although new interventions are welcome for these debilitating disorders, we are concerned that these approvals share common critical features, and could further lower the bar in the evaluation of treatments for mental disorders.

中文翻译：

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美国食品和药物管理局批准了艾司他敏和布雷沙龙的使用。

2019年3月，美国食品和药物管理局（FDA）批准了两种新的抗抑郁药：依沙酮胺可用于治疗性抑郁症，而布雷克索龙可用于产后抑郁症。两者都具有突破性的称号，一种针对药物的快速审查程序，“旨在治疗严重的疾病，初步的临床证据表明，该药物可能在临床上具有重要意义的终点方面比现有疗法有实质性改善”。尽管欢迎采取新的干预措施来治疗这些使人衰弱的疾病，但我们担心这些批准具有共同的关键特征，并且可能进一步降低对精神疾病治疗的评估标准。