In addition, the Company announced today that it has implemented a voluntary pause on enrollment for new patients in its ongoing clinical studies in major depressive disorder (MDD) and bipolar depression (BPD), following an analysis of neuropsychiatric adverse events in these studies. Participants currently enrolled in the randomized controlled psychiatry studies and associated OLE studies will continue on study. The observed events, the rate of these events and their severity, are consistent with the known safety and tolerability profile of azetukalner and its mechanism; however, such adverse events had not previously been seen in the Phase 2 X‑NOVA clinical study in MDD. The enrollment pause is being implemented as a precautionary measure by Xenon in consultation with its Data Safety Monitoring Board (DSMB) and is expected to be temporary. Xenon is working to evaluate potential dosing modifications to help mitigate these adverse events. This voluntary action does not impact ongoing epilepsy studies.
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