FDA Halts Newron's Schizophrenia Study After Patient Death
The FDA has paused patient enrollment in Newron Pharmaceuticals' Phase 3 ENIGMA-TRS 2 trial for its schizophrenia drug, evenamide, following a patient death. The death occurred outside the U.S. and was deemed unrelated to the drug. The trial, which is testing evenamide for treatment-resistant schizophrenia, continues in other countries, including India and Argentina. Evenamide is an antipsychotic agent that works by blocking voltage-gated sodium channels to restore glutamate balance. Phase 2 data showed that evenamide reduced disease severity and psychosis symptoms, with benefits maintained over a year. Newron is also conducting another study, ENIGMA-TRS 1, across multiple regions. 
