FDA Flags Safety Concerns After Four Deaths in Evenamide Schizophrenia Trial
Source Summary
The FDA identified a potential safety signal following four reported deaths among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, according to Newron Pharmaceuticals. The deaths prompted regulatory scrutiny of the novel drug candidate.
Why it matters
Deaths in clinical trials of an investigational psychiatric drug trigger FDA safety review and may affect the drug's regulatory pathway and patient access.
What remains uncertain
The source does not specify the cause of the deaths or the stage of regulatory review.
