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抑郁症新药!Caplyta辅助治疗双相抑郁症III期成功:显著改善抑郁症状和严重程度!

2020-09-11 09:58:08生物谷
核心提示:结果显示,与安慰剂相比,每日一次lumateperone 42mg显著改善了抑郁症状,在主要终点(改善抑郁症,p=0.0206)和关键次要终点(改善抑郁严重程度,p=0.0082)均取得了统计学上意义的结果。

  Intra-Cellular Therapies(ICT)SHIYIJIAZHUANZHUYUKAIFACHUANGXINLIAOFAZHIZHONGSHUSHENJINGXITONG(CNS)JIBINGDESHENGWUZHIYAOGONGSI。JINRI,GAIGONGSIGONGBULEIIIQILINCHUANGSHIYAN(Study 401,401YANJIU)DEYANGXINGDINGXIANJIEGUO,GAIYANJIUPINGGULECaplyta(lumateperone)ZUOWEILIYANHUOBINGWUSUANYANDEFUZHULIAOFA,YONGYUZHILIAOYUSHUANGXIANGIXINGHUOSHUANGXIANGIIXINGZHANGAIXIANGGUANZHONGXINGYIYUFAZUO(major depressive episode)。JIEGUOXIANSHI,YUANWEIJIXIANGBI,MEIRIYICIlumateperone 42mgXIANZHUGAISHANLEYIYUZHENGZHUANG,ZAIZHUYAOZHONGDIAN(GAISHANYIYUZHENG,p=0.0206)HEGUANJIANCIYAOZHONGDIAN(GAISHANYIYUYANZHONGCHENGDU,p=0.0082)JUNQUDELETONGJIXUESHANGYIYIDEJIEGUO。

  SHUJUFABUHOU,ICTGONGSIGUJIABAOZHANG74%。CaplytaYU2019NIAN12YUEHUODEMEIGUOSHIPINHEYAOWUGUANLIJU(FDA)PIZHUN,YONGYUJINGSHENFENLIEZHENGCHENGRENHUANZHEDEZHILIAO。GENJU401YANJIUJIEGUO,YIJIZHIQIANGONGBUDEDANYAOZHILIAOIIIQI404YANJIUJIEGUO,ICTGONGSIJIHUAZAI2020NIANDIHUO2021NIANCHUXIANGMEIGUOFDATIJIAOYIFENBUCHONGXINYAOSHENQING(sNDA),JIANGCaplytaZUOWEIDANYAOLIAOFAHEFUZHULIAOFA,YONGYUZHILIAOSHUANGXIANGIXINGHUOIIXINGZHANGAIHUANZHEDESHUANGXIANGYIYUZHENG。

  402HAOYANJIUZAIQUANQIU5GEGUOJIAJINXING,BAOKUOMEIGUO。YANJIUZHONG,529LIBANYOUSHUANGXIANGIXINGHUOSHUANGXIANGIIXINGZHANGAIDEZHONGDUZHIZHONGDUZHONGXINGYIYUFAZUOHUANZHEYI1:1:1DEBILISUIJIFENPEI,FENBIEMEIRIYICIFUYONGlumateperone 42mg、28mg、ANWEIJI,TONGSHIJIXUSHIYONGLIYANHUOBINGWUSUANYANZUOWEIQINGXUWENDINGJI。

  JIEGUOXIANSHI,lumateperone 42mgDADAOLEZHUYAOZHONGDIAN:ZAIZHILIAODI6ZHOU(SHIYANZHONGDIAN),CAIYONGMENGGEMALIHEASIBOGEYIYUZHENGDENGJILIANGBIAO(MADRS)ZONGPINGFENXIANGDUIJIXIANDEBIANHUAJINXINGPINGJIA,YUANWEIJIZUXIANGBI,lumateperone 42mgZUZAIGAISHANYIYUZHENGFANGMIANBIAOXIANCHUTONGJIXUEYIYIDEXIANZHUGENGDAGAISHAN。ZAIYIXIANGXINGZHILIAO(ITT)YANJIUQUNTIZHONG,lumateperone 42mgZUXIANGDUIJIXIANDEZUIXIAOERCHENGFA(LS)PINGJUNXIAJIANGZHIWEI16.9FEN,ANWEIJIZUWEI14.5FEN(LSPINGJUNCHAYI=2.4FEN,XIAOYINGDAXIAO=0.27,p=0.0206)。

  CIWAI,lumateperone 42mgZUYEDADAOLEGUANJIANCIYAOZHONGDIAN:JILINCHUANGZONGTIYINXIANG-SHUANGXIANGZHANGAIBANJIBINGYANZHONGCHENGDULIANGBIAO(CGI-BP-S)YIYUPINGFENYOUTONGJIXUEYIYIDEGAISHAN(p=0.0082;XIAOYINGDAXIAO=0.31)。

  GAIYANJIUZHONG,YUANWEIJIZUXIANGBI,lumateperone 28mgZUZAIYIYUZHENGZHUANGFANGMIANXIANSHIJILIANGXIANGGUANGAISHANQUSHI,DANJIEGUOMEIYOUTONGJIXUEYIYI。RANER,YUANWEIJIZUXIANGBI,lumateperone 28mgZUZAICGI-BS-SSHANGYUANWEIJIZUXIANGBIYOUTONGJIXUEYIYIDEXIANZHUGAISHAN。

  GAISHIYANZHONG,lumateperoneDENAISHOUXINGLIANGHAO,ANQUANXINGLIANGHAO。BULIANGSHIJIANDUOWEIQINGDUZHIZHONGDU,YUYIWANGSHUANGXIANGYIYUHEJINGSHENFENLIEZHENGYANJIUZHONGSUOJIANXIANGSI,WEIGUANCHADAOXINDEBULIANGSHIJIAN。ZUICHANGJIANDEBULIANGSHIJIAN(FASHENGLV≥5%,QIEZHISHAOSHIANWEIJIDE2BEI)SHISHISHUI、TOUYUNHEEXIN。JINGZUOBUAN、ZHUITIWAIXIZHENGZHUANGHETIZHONGBIANHUADEFASHENGLVYUANWEIJIXIANGSI。ZHEIXIEFAXIANTIGONGLEJINYIBUDEZHENGJU,ZHICHIlumateperoneZAIBUTONGHUANZHEQUNTIZHONGDELIANGHAOANQUANXINGHENAISHOUXING。

  SHUANGXIANGIXINGHESHUANGXIANGIIXINGQINGGANZHANGAISHIYANZHONGDE、GAODULIUXINGDEJINGSHENJIBING。ZHEIXIEJIBINGDETEDIANSHIFANFUFAZUODEZAOKUANGZHENGHUOQINGDUZAOKUANGZHENGJIAZAZHECHENGWEISHUANGXIANGYIYUDEZHONGXINGYIYUFAZUO。SHUANGXIANGIHESHUANGXIANGIIGEZHANSHUANGXIANGQINGGANZHANGAIHUANZHEZONGSHUDEYIBAN。SHUANGXIANGYIYUSHISHUANGXIANGQINGGANZHANGAIZUICHANGJIANDELINCHUANGBIAOXIAN。ZHEIXIEFAZUOWANGWANGCHIXUSHIJIANGENGZHANG,FUFALVGENGGAO,YUZAOKUANG/QINGDUZAOKUANGFAZUOXIANGBIYUHOUGENGCHA。SHUANGXIANGYIYURENGRANSHIYIGEYANZHONGBUZUDEYILIAOXUQIU,ZHIYOUJIGEFDAPIZHUNDELIAOFAKEYONG,ZHEIXIELIAOFATONGCHANGYUNAISHOUXINGWENTIYOUGUAN。

  CaplytaDEHUOXINGYAOWUCHENGFENWEIlumateperone,ZHEISHIYIZHONGSHOUCHUANGDE(first-in-class)XIAOFENZIYAOWU,KEXUANZEXINGQIETONGSHIDIAOJIE5-QIANGSEAN、DUOBAANJIGUANSUANZHEI3ZHONGSHEJIYANZHONGJINGSHENJIBINGDESHENJINGDIZHITONGLU。YAOXIAOXUEYANJIUBIAOMING,lumateperoneZUOWEIYIZHONGQIANGXIAOJIEKANGJIZAI5-QIANGSEAN5-HT2ASHOUTISHANGJUYOUGAOJIEHEQINHELI、ZUOWEIYIZHONGJIEKANGJIZAITUCHUHOUD2SHOUTISHANGYOUZHONGDENGJIEHEQINHELI、ZUOWEIYIZHONG5-QIANGSEANZHUANYUNTI(SERT)ZAISHEQUYIZHIJIDUID1SHOUTIJUYOUZHONGDENGDEQINHELI(ZHEIKENENGYOUZHUYUAMPAHENMDASHOUTIDEJIANJIEJIHUO)。ZHEIXIESHOUTIBEIRENWEIZAIJINGSHENFENLIEZHENG、SHUANGXIANGQINGGANZHANGAI、YIYUZHANGAIHEQITASHENJINGJINGSHENJIBINGZHONGQIZHONGYAOZUOYONG。TIWAIYANJIUBIAOMING,YUD2SHOUTIXIANGBI,lumateperoneDUI5-HT2ASHOUTIDEQINHELIGAOCHUYUE60BEI。

  ZAIMEIGUO,FDAYIYU2017NIAN11YUESHOUYUlumateperoneZHILIAOJINGSHENFENLIEZHENGDEKUAISUTONGDAODIWEI。CHULEJINGSHENFENLIEZHENGZHIWAI,ICTGONGSIYEZHENGZAIKAIFAlumateperoneZHILIAOSHUANGXIANGYIYU、YIYUZHENGHEQITASHENJINGJINGSHENHESHENJINGJIBING。

  YEJIEDUICaplytaDEQIANJINGFEICHANGKANHAO,YIYAOSHICHANGDIAOYANJIGOUEvaluatePharmaYUCE,CaplytaZAI2026NIANDEXIAOSHOUEJIANGDADAO20YIMEIYUAN,QIZHONGYIBANJIANGLAIZIJINGSHENFENLIEZHENG,LINGYIBANJIANGLAIZISHUANGXIANGYIYUZHENG。(SHENGWUGUBioon.com)

  YUANWENCHUCHU:Intra-Cellular Therapies Announces Positive Topline Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy in Patients with Bipolar Depression

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