FDA Halts Newron's U.S. Enrollment in Schizophrenia Study After Patient Death
The FDA has temporarily paused Newron Pharmaceuticals' enrollment of new patients in the U.S. for its Phase 3 ENIGMA-TRS 2 trial, following a patient death. The trial is testing evenamide, an antipsychotic agent for treatment-resistant schizophrenia. The death occurred outside the U.S. and was deemed unrelated to the drug. Despite the pause in the U.S., the trial continues in other countries, including India and Argentina. Evenamide works by modulating glutamate levels in the brain, and previous studies have shown it reduces schizophrenia symptoms. Newron is also conducting another trial, ENIGMA-TRS 1, across multiple regions. 
