Intra-Cellular Therapies, Inc. announced that it has recently submitted a supplemental New Drug Application (sNDA) to the FDA for Capylta  (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults, as adjunctive therapy to antidepressants

Intra Cellular Therapes，Inc.宣布，它最近向FDA提交了Capylta（lumateperone）的补充新药申请（sNDA），用于治疗成人重度抑郁症（MDD），作为抗抑郁药的辅助治疗

“MDD is a highly prevalent condition with a significant need for efficacious, safe, and well-tolerated medicines, as more than half of patients do not adequately respond to an antidepressant alone,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies.

“MDD是一种非常普遍的疾病，非常需要有效，安全且耐受性良好的药物，因为超过一半的患者对单独的抗抑郁药没有足够的反应，”细胞内治疗执行副总裁兼首席医疗官Suresh Durgam博士说。

“Given Caplyta' s efficacy and safety profile, we believe Caplyta can become a first-choice treatment for the adjunctive treatment of MDD pending FDA approval, and we look forward to working with the FDA during this review process.”.

“鉴于Caplyta的疗效和安全性，我们相信Caplyta可以成为FDA批准之前MDD辅助治疗的首选治疗方法，我们期待在审查过程中与FDA合作。”。

Studies 501 and 502 are two positive Phase III global, double-blind, placebo-controlled studies in patients with a primary diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who have had an inadequate response to ongoing anti-depressant therapy.

根据《精神障碍诊断和统计手册》第五版（DSM-5）标准，研究501和502是两项阳性III期全球双盲安慰剂对照研究，主要诊断为MDD的患者对正在进行的抗抑郁治疗反应不足。

These studies form the basis of the sNDA..

这些研究构成了sNDA的基础。。

Caplyta, added to an antidepressant, demonstrated robust efficacy for the treatment of MDD in the primary endpoint, the Montgomery Asberg Depression Rating Scale (MADRS) total score, with a large separation versus placebo of 4.9 points (effect size 0.61) in Study 501 and 4.5 points (effect size 0.56) versus placebo in Study 502..

添加到抗抑郁药中的Caplyta在主要终点蒙哥马利-阿斯伯格抑郁评定量表（MADRS）总分中显示出治疗MDD的强大疗效，与安慰剂相比，研究501中的4.9分（效应大小0.61）和研究502中的4.5分（效应大小0.56）与安慰剂相比有较大的差异。。

Caplyta's efficacy is complemented with a favorable safety and tolerability profile - including a favorable metabolic, weight and movement disorder profile. In the pooled safety data for Studies 501 and 502, the most commonly reported adverse events that were observed at a rate greater than or equal to 5% for lumateperone and greater than twice the rate of placebo were dizziness, dry mouth, somnolence/sedation, nausea, and fatigue.

。在研究501和502的汇总安全性数据中，最常见的不良事件是头晕，口干，嗜睡/镇静，恶心和疲劳，其发生率大于或等于5%的lumateperone和大于安慰剂的两倍。

Importantly, metabolic and weight changes were similar to placebo and the rates of extrapyramidal symptoms were low..

重要的是，代谢和体重变化与安慰剂相似，锥体外系症状的发生率很低。。

Condition: Depression

条件：抑郁症

Type: drug

类型：药物