Patient death prompts FDA pause on Newron’s Phase 3 schizophrenia study

The U.S. Food and Drug Administration temporarily paused U.S. enrollment in Newron Pharmaceuticals’ Phase 3 schizophrenia trial after a patient died at a non-U.S. study site, although the death was determined to be unrelated to the drug.

The pause only affects U.S. sites, while the global trial of the investigational drug evenamide continues, supported by an independent safety board that found no increased mortality risk linked to the treatment.

Overall, the situation reflects routine safety oversight in clinical trials, with regulators reviewing the event before allowing U.S. enrollment to resume.