该机构指出，在所有研究中接受evenamide治疗的患者中出现了四例死亡，而接受安慰剂的患者中仅有一例死亡。
FDA将这四例死亡视为潜在的安全信号，因为无法明确排除致命性心律失常机制的可能性，Newron表示。
The agency noted four deaths among patients who received evenamide across all studies, compared with one death among those given a placebo The FDA characterized the four deaths as a potential safety signal because a fatal arrhythmic mechanism could not be definitively excluded, Newron said.
该药物在治疗抵抗性精神分裂症患者中进行测试，这是一种影响思维、情感和对现实感知的严重精神疾病。
此反馈是在FDA今年早些时候因一名患者突发死亡而对晚期evenamide试验的新患者入组实施临床暂停之后发布的，尽管该事件与治疗无关，Newron称试验研究者认为四例死亡中有三例与evenamide无关。由于两例尸检未确定死亡原因，其中一例被认为可能与药物有关。
The drug was tested in people with treatment-resistant schizophrenia, a serious mental illness that affects thinking, emotions and perception of reality The feedback comes after the FDA earlier this year placed a clinical hold on new patient enrollment in a late-stage trial of evenamide following a patient's sudden death, although the event was unrelated to the treatment Newron said trial investigators considered three of the four deaths unrelated to evenamide.
公司表示在其前临床和临床安全数据中未发现心脏异常或不规则节律的模式。
Newron正在审查FDA的反馈以及在evenamide开发计划中产生的更广泛的安全数据，并计划提交回应。
Newron称临床暂停仍然有效，试验在美国以外地区的入组仍在继续。
One was considered possibly related because two autopsies did not determine a cause of death The company said it has not identified a pattern of heart abnormalities or irregular rhythms in its preclinical and clinical safety data Newron is reviewing the FDA's feedback and the broader safety data generated across the evenamide development program and it plans to submit a response Newron said the clinical hold remains in place and enrollment in the trial is continuing outside the US