FDA Halts Enrollment in Newron's ENIGMA-TRS 2 Study in U.S. Following Safety Concerns
Newron Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has placed a hold on the enrollment of new patients in the U.S. sites of its Phase III ENIGMA-TRS 2 study. This decision follows the sudden death of a study participant at a clinical site outside the United States, which was assessed by the investigator as unrelated to the study treatment. Despite this, the FDA has requested further information to ensure patient safety. The ENIGMA-TRS 2 study is part of a larger program evaluating the efficacy and safety of evenamide, a potential treatment for treatment-resistant schizophrenia (TRS). The study aims to enroll at least 400 patients in a 12-week, randomized, double-blind, placebo-controlled trial. Newron is working closely with the FDA to resolve the hold and resume enrollment in the U.S. 
