The Food and Drug Administration has flagged four deaths among patients treated with an experimental schizophrenia drug as a potential safety signal, in written feedback explaining why a clinical hold on the drug’s U.S. trial sites remains in place.
The drug, evenamide, is being developed by Italy-based Newron Pharmaceuticals for people with treatment-resistant schizophrenia, a severe form of the illness that responds poorly to existing medications. According to the company, the agency noted four deaths across all of the drug’s studies, compared with one among patients receiving placebo, and said a fatal irregular-heartbeat mechanism could not be definitively excluded — a known concern with some drugs in evenamide’s class, the sodium channel blockers. Newron’s shares fell 5.7 percent after the disclosure.
The company disputes the implication. Investigators judged three of the four deaths unrelated to the drug, with one considered possibly related because autopsies did not establish a cause. Newron says it has reviewed more than 10,000 electrocardiograms from about 700 treated subjects without finding a pattern of cardiac abnormalities, and that adjusted for treatment duration, mortality rates were actually lower on evenamide than on placebo. The firm is preparing a response to the agency and evaluating additional cardiac screening.
The hold, first imposed on new U.S. enrollment in April, does not affect the trial outside the United States, where enrollment continues. A sister study is expected to complete enrollment by mid-October, with first results due in early 2027. No American patients have received the drug in the halted trial.
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