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，細胞內療法公司（納斯達克股票代碼：ITCI）報告了用於預防成年精神分裂症患者復發的42毫克盧馬培隆的304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，接受盧馬佩龍治療的患者在雙盲治療階段的復發時間明顯長於接受安慰劑的患者（p=0.0002）。
There were 18 relapses (16.4%) in the lumateperone group versus 44 relapses (38.6%) in the placebo group.
lumateperone組有18例復發（16.4％），而安慰劑組有44例復發（38.6％）。
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Treatment with lumateperone was associated with a 63% reduction in risk of relapse versus placebo.
與安慰劑相比，使用盧馬培隆治療可使復發風險降低63％。
Lumateperone also met the key secondary endpoint, time to all-cause discontinuation during the double-blind phase (p=0.0007).
Lumateperone還達到了關鍵的次要終點，即在雙盲階段全因停藥的時間（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.
Lmateperone總體上是安全的，耐受性良好。最常報告的不良事件是頭痛，發生率大於或等於5％，是安慰劑的兩倍。
"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，其特徵是發生急性精神病發作，累積惡化疾病預後。控制症狀和預防復發對於改善患者的長期預後至關重要。細胞內療法執行副總裁兼首席醫學官蘇雷什·杜爾加姆博士說，我們很高興304研究（一項隨機戒斷試驗）的結果顯示出療效以及良好的安全性和耐受性，這爲持續長期使用lumateperone治療的益處提供了支持。
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）適用於成人精神分裂症和與II或II型雙相情感障礙（雙相抑鬱症）相關的抑鬱發作，可作爲單一療法以及鋰或丙戊酸的輔助療法。
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，研究501和502中將42毫克的lumateperone用作重度抑鬱症抗抑鬱藥的輔助療法的數據顯示，與第6周的安慰劑相比，蒙哥馬利和阿斯伯格抑鬱評級量表的總分在統計學上顯著且具有臨床意義的降低。
Price Action: ITCI stock is up 0.72% at $86.79 at last check Tuesday.
價格走勢：在週二的最後一次檢查中，ITCI股價上漲0.72％，至86.79美元。
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照片：Shutterstock
