Intra-Cellular Therapies' Treatment Reduces Schizophrenia Relapse Risk 63%
Intra-Cellular Therapies' Treatment Reduces Schizophrenia Relapse Risk 63%
On Tuesday, Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) reported results from Study 304 of lumateperone 42 mg for the prevention of relapse in adult patients with schizophrenia.
週二，納斯達克（NASDAQ:ITCI）的Intra-Cellular Therapies公司報告了魯馬特貝龍（lumateperone）42毫克用於預防成人精神分裂症患者復發的304號研究結果。
On the primary endpoint, the time to relapse during the double-blind treatment phase was significantly longer in patients receiving lumateperone than in those receiving placebo (p=0.0002).
在主要終點上，雙盲治療階段復發時間在接受魯馬特貝龍治療的患者中明顯長於接受安慰劑治療的患者（p=0.0002）。
There were 18 relapses (16.4%) in the lumateperone group versus 44 relapses (38.6%) in the placebo group.
魯馬特貝龍組中有18次復發（16.4%），而安慰劑組中有44次復發（38.6%）。
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Treatment with lumateperone was associated with a 63% reduction in risk of relapse versus placebo.
魯馬特普隆治療與安慰劑相比，可使復發風險降低63%。
Lumateperone also met the key secondary endpoint, time to all-cause discontinuation during the double-blind phase (p=0.0007).
魯馬特貝龍還達到了關鍵的次要終點，在雙盲階段的全因終止時間上（p=0.0007）。
Lmateperone was generally safe and well tolerated. The most commonly reported adverse event observed at a rate greater than or equal to 5% and twice the placebo rate was headache.
魯馬特貝龍一般是安全且耐受良好的。最常報告的不良事件，發生率高於或等於5%且是安慰劑速率的兩倍，爲頭痛。
"Schizophrenia is a chronic, serious mental illness characterized by the occurrence of acute psychotic episodes that cumulatively worsen disease prognosis. The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes. We are very pleased that the results from Study 304, a randomized withdrawal trial, demonstrated efficacy along with favorable safety and tolerability which support the benefit of continued long-term treatment with lumateperone," said Dr. Suresh Durgam, executive vice president and chief medical officer of Intra-Cellular Therapies.
「精神分裂症是一種慢性、嚴重的精神疾病，其特點是急性精神病發作的頻繁發生，這些發作累積地惡化了疾病預後。控制症狀並預防復發對改善患者的長期預後至關重要。我們非常高興地得知從304號研究，一個隨機撤退試驗，證實了魯馬特貝龍的療效以及良好的安全性和耐受性，支持繼續長期治療的好處。」 Intra-Cellular Therapies的首席醫療官蘇雷什·杜爾加姆博士表示。
Caplyta (lumateperone) is indicated in adults for schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Caplyta（lumateperone）適用於成人的精神分裂症和雙相I或II型隨附抑鬱症狀（雙相抑鬱症）的單藥治療，以及與鋰礦或丙戊酸鹽聯合治療。
Earlier this year, data from Studies 501 and 502 of lumateperone 42 mg as adjunctive therapy to antidepressants for major depressive disorder showed a statistically significant and clinically meaningful reduction in the Montgomery and Asberg Depression Rating Scale total score compared to placebo at Week 6.
今年早些時候，Lumateperone 42毫克輔助抗抑鬱藥治療主要抑鬱障礙的501和502研究數據顯示，在第6周與安慰劑相比，Montgomery-阿斯伯格抑鬱評定量表總評分有統計學意義的臨床顯著下降。
Price Action: ITCI stock is up 0.72% at $86.79 at last check Tuesday.
股價走勢：ITCI股價在上週二最後一次查詢時上漲0.72％，報86.79美元。
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Photo: Shutterstock
Photo: shutterstock
譯文內容由第三人軟體翻譯。
