USFDA Flags 4 Deaths in Newron's Experimental Schizophrenia Drug Trials
Bengaluru: Italy's Newron Pharmaceuticals said on Thursday the US FDA had identified four deaths among patients treated with its experimental schizophrenia drug in feedback following the agency's earlier decision to place a clinical hold on the treatment's trial in the US.
Shares of the Switzerland-listed company fell 5.7% in afternoon trading after the US Food and Drug Administration raised safety concerns, including the potential risk of irregular heart rhythms.
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The agency noted four deaths among patients who received evenamide across all studies, compared with one death among those given a placebo
The FDA characterized the four deaths as a potential safety signal because a fatal arrhythmic mechanism could not be definitively excluded, Newron said.
The drug was tested in people with treatment-resistant schizophrenia, a serious mental illness that affects thinking, emotions and perception of reality
The feedback comes after the FDA earlier this year placed a clinical hold on new patient enrollment in a late-stage trial of evenamide following a patient's sudden death, although the event was unrelated to the treatment
Newron said trial investigators considered three of the four deaths unrelated to evenamide. One was considered possibly related because two autopsies did not determine a cause of death
The company said it has not identified a pattern of heart abnormalities or irregular rhythms in its preclinical and clinical safety data
Newronis reviewing the FDA's feedback and the broader safety data generated across the evenamide development program and it plans to submit a response
Newron said the clinical hold remains in place and enrollment in the trial is continuing outside the US
