The FDA maintained a clinical hold on US enrollment in ENIGMA-TRS 2 after identifying a potential risk of fatal arrhythmias with evenamide.
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Across clinical studies, 4 deaths occurred among evenamide-treated patients and 1 among placebo recipients; investigators considered 1 evenamide death possibly treatment-related.
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Newron reported mortality rates of 1.31 deaths per 100 patient-years with evenamide and 1.81 with placebo after adjustment for treatment exposure.
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Newron said its database of more than 10,000 ECGs from approximately 700 evenamide-treated participants showed no consistent pattern of cardiac abnormalities or arrhythmias.
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Enrollment in ENIGMA-TRS 2 continues outside the US, while Newron reviews FDA feedback and considers additional cardiac screening and monitoring measures.
Swedish study finds two-way associations between premenstrual disorders and psychiatric conditions, with strongest links involving depression, anxiety, attention-deficit/hyperactivity disorder, bipolar disorder, and personality disorders.
