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Teva Pharmaceuticals And Medincell Say Phase 3 Efficacy Results From SOLARIS Trial For Schizophrenia Showed That TEV-'749 Met Its Primary Endpoint As Measured By A Change In The PANSS Total Score From Baseline After 8 Weeks Compared To Placebo

Teva Pharmaceuticals And Medincell Say Phase 3 Efficacy Results From SOLARIS Trial For Schizophrenia Showed That TEV-'749 Met Its Primary Endpoint As Measured By A Change In The PANSS Total Score From Baseline After 8 Weeks Compared To Placebo

梯瓦制药和Medincell表示,SOLARIS精神分裂症试验的3期疗效结果显示,TEV-'749达到了其主要终点,衡量标准是与安慰剂相比,8周后PANSS总分与基线相比的变化
Benzinga ·  05/08 18:38
  • The study met its primary endpoint achieving clinically meaningful and statistically significant reductions across all TEV-'749 dose groups versus placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a widely used assessment tool for schizophrenia symptom severity
  • TEV-'749 was well tolerated, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date: additional safety data is being collected as part of the long-term follow-up SOLARIS study
  • TEV-'749 is being developed by Teva as a once-monthly subcutaneous long-acting injection of olanzapine with the use of SteadyTeq technology, a copolymer technology proprietary to Medincell
  • 在广泛使用的精神分裂症症状严重程度评估工具阳性和阴性综合征量表(PANSS)总分中,与安慰剂相比,该研究达到了其主要终点,在所有TEV-'749剂量组中实现了具有临床意义和统计学意义的显著降低
  • TEV-'749耐受性良好,迄今未观察到注射后精神错乱/镇静综合征(PDSS)的发生率:作为长期随访SOLARIS研究的一部分,正在收集更多安全数据
  • TEV-'749由Teva开发,是一种每月一次的奥氮平皮下长效注射剂,采用了SteadyTeq技术,这是一种专属于Medincell的共聚物技术

译文内容由第三方软件翻译。


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