FDA批准CAPLYTA联合抗抑郁药治疗成人重性抑郁障碍，两项三期试验MADRS评分差4.9分与4.5分
强生公司11月6日宣布，美国食品药品管理局（FDA）已批准CAPLYTA（lumateperone）与口服抗抑郁药联合使用，用于治疗成人重性抑郁障碍（MDD）。这是CAPLYTA获批的第四个适应症；该药此前已获批用于成人精神分裂症，以及双相I型和II型障碍相关抑郁发作。强生表示，这是其收购Intra-Cellular Therapies之后的首个获批事项，用药起始剂量即为42毫克有效剂量、无需滴定。
批准依据为两项全球三期双盲安慰剂对照试验501和502，两项均达到主要终点：以蒙哥马利—阿斯伯格抑郁评定量表（MADRS）总分衡量，CAPLYTA组在第6周与安慰剂的差值在501试验为-4.9分（效应量0.61）、502试验为-4.5分（效应量0.56）。为期26周的503开放标签延展研究中，80%的患者达到治疗反应，65%在6个月时达到缓解（定义为MADRS总分不高于10分）。
强生在发布中称，重性抑郁障碍影响约2,200万美国成年人，约三分之二的患者在现有抗抑郁治疗下仍有残留症状。公司列出的常见副作用包括嗜睡、头晕、恶心、口干、疲劳和腹泻，并称关键试验中体重与代谢变化与安慰剂相近。以上疗效与安全性数据均出自强生公司发布原文。
FDA Approves CAPLYTA as Adjunctive Therapy for Major Depressive Disorder; Phase 3 MADRS Separations of 4.9 and 4.5 Points
Johnson & Johnson announced on November 6 that the U.S. Food and Drug Administration (FDA) has approved CAPLYTA (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. It is the fourth approved indication for CAPLYTA, which was previously approved for schizophrenia in adults and for depressive episodes associated with bipolar I or II disorder. Johnson & Johnson said it is the first approval under its leadership following its acquisition of Intra-Cellular Therapies, and that treatment starts at the effective 42 mg dose with no titration needed.
The approval rests on two global Phase 3 double-blind, placebo-controlled trials, Studies 501 and 502, which both met their primary endpoints. On the Montgomery-Asberg Depression Rating Scale (MADRS), the separation from placebo at six weeks was -4.9 points (effect size 0.61) in Study 501 and -4.5 points (effect size 0.56) in Study 502. In the 26-week open-label extension Study 503, 80% of patients responded to treatment and 65% experienced remission, defined as a MADRS total score of 10 or less, at six months.
Johnson & Johnson said MDD affects about 22 million American adults and that two in three people continue to experience residual symptoms despite antidepressant treatment. The company listed common side effects including sleepiness, dizziness, nausea, dry mouth, fatigue, and diarrhea, and said weight and metabolic changes in the pivotal trials were similar to placebo. The efficacy and safety figures above are taken from the company's release.
来源：强生公司
发布：GSM·美国（发布链接）
图片来源：图中是强生公司位于新泽西州新不伦瑞克的总部大楼。来源：Wikimedia Commons, Public domain, user:ekem。
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