“产后抑郁症是一种很严重的疾病,甚至严重到可能会危及生命,”食药局药物评估研究中心精神病药物研究分部的代理主管蒂芙尼•法尔基奥内博士在一份声明中说道。
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
“这份许可标志着一款治疗产后抑郁症的药物首次获得专门审批,这也为人们提供了一种重要的新疗法。”
There are limitations to the new drug, brexanolone, which will be marketed as Zulresso. It is delivered by infusion over 60 hours, during which a new mother must remain in a certified medical center, under supervision should she get dizzy or faint, as several patients did in clinical trials.
Brexanolone这款新药将以Zulresso的名称推向市场,但目前它还有局限性。这种药需要在60多个小时里进行注射,在此期间,新产妇必须留在一家有执照的医疗中心,在医生的监督下接受治疗,因为她可能会像接受临床试验的几个病人那样有眩晕或昏厥的症状。
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