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News
The FDA has flagged a potential safety signal in Newron Pharmaceuticals' experimental schizophrenia drug, evenamide, after four patient deaths were recorded across its clinical studies — compared to just one in the placebo group. The agency can't rule out a fatal irregular heart rhythm as a cause, and a clinical hold on U.S. enrollment remains in place. Newron says it's reviewing the data and plans to respond to the FDA.
The U.S. FDA has raised serious safety concerns about evenamide, an experimental drug from Italy's Newron Pharmaceuticals being developed for treatment-resistant schizophrenia. The agency flagged four deaths among patients who received evenamide across all studies, compared to just one death in the placebo group — a disparity that prompted the FDA to characterize the findings as a potential safety signal, particularly because a fatal arrhythmic (irregular heart rhythm) mechanism could not be definitively ruled out.
Newron's stock dropped 5.7% following the news. The company noted that trial investigators deemed three of the four deaths unrelated to evenamide, while one was classified as "possibly related" after two autopsies failed to determine a cause of death. Newron maintains it has not identified a pattern of cardiac abnormalities in its preclinical or clinical safety data, and is reviewing the FDA's feedback before submitting a formal response. Enrollment in the trial is continuing outside the U.S.
By the Numbers:
Why it matters: Treatment-resistant schizophrenia is a serious and difficult-to-treat condition with limited therapeutic options, making new drugs highly anticipated. The FDA's ongoing clinical hold on U.S. enrollment — and the unresolved cardiac safety signal — puts evenamide's development path in question, highlighting the rigorous safety bar regulators apply when evaluating drugs for vulnerable psychiatric populations.
