Newron reports five deaths in schizophrenia trial as FDA keeps hold on evenamide study

Newron Pharmaceuticals disclosed that five participants have died in its late-stage schizophrenia trial, with four deaths among those receiving the investigational drug evenamide and one death among placebo recipients.

The FDA placed a partial clinical hold on the Phase 3 ENIGMA-TRS 2 trial earlier this year after a death occurred at an overseas site, which was judged unrelated to the drug but the hold remained in effect.

The agency’s concern centers on evenamide’s mechanism as a selective voltage-gated sodium channel blocker, a class that can potentially cause cardiac arrhythmias or seizures.

Across all studies, the four deaths in the evenamide arm represent an incidence of about 0.56%, according to Newron’s latest data.