US FDA flags four deaths in Newron's schizophrenia drug studies

Oct 8 — 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.

Here are some ‌details:

• 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

• Newron is 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

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by ​Shreya Biswas)

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