及时止损:创伤后应激障碍(PTSD)药物Tonmya(TNX-102 SL)折戟沉沙

2020-02-06 Allan MedSci原创

Tonix是一家临床阶段的生物制药公司,今日宣布,该公司已决定停止Tonmya(TNX-102 SL,5.6 mg盐酸环苯扎林舌下片)治疗创伤后应激障碍(PTSD)的III期临床研究。

Tonix是一家临床阶段的生物制药公司,今日宣布,该公司已决定停止TonmyaTNX-102 SL5.6 mg盐酸环苯扎林舌下片)治疗创伤后应激障碍(PTSD)的III临床研究。根据中期分析结果,IDMC(独立数据监测委员会)建议停止试验,因为PTSD症状严重程度从基线的总体变化并未得到显著改善。值得注意的是,这些参与者的初步安全性数据未显示任何严重和/或未预期的不良事件,因此终止研究的决定与安全性无关。

创伤后应激障碍( PTSD)是指个体经历、目睹或遭遇到一个或多个涉及自身或他人的实际死亡,或受到死亡的威胁,或严重的受伤,或躯体完整性受到威胁后,所导致的个体延迟出现和持续存在的精神障碍。


原始出处:

https://www.firstwordpharma.com/node/1698605

本文系梅斯医学(MedSci)原创编译整理,转载需授权!

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Tonix停止对Tonmya进行军事相关创伤后应激障碍(PTSD)的后期研究

Tonix制药表示正停止对Tonmya(一种舌下含服的环苯扎林片状透明胶囊制剂)进行III期HONOR研究,Tonmya起初用于治疗军事相关的创伤后应激障碍(PTSD)。根据Tonix的说法,一项中期分析显示,在第12周,主要终点与安慰剂分离不足。