FDA Maintains U.S. Enrollment Hold On Newron's Phase 3 ENIGMA-TRS 2 Schizophrenia Study

India, Sept. 27 -- Newron Pharmaceuticals (NP5.DE,NWRN.SW) said the U.S. Food and Drug Administration (FDA) has informed the company that a hold on the enrollment of new patients at U.S. sites participating in the Phase 3 ENIGMA-TRS 2 study of evenamide will remain in place.

The company said patient enrollment in the trial continues outside the United States and that it expects to receive written communication from the FDA outlining additional details regarding the decision, including any protocol modifications that may be required before the hold can be lifted.

Evenamide is an investigational therapy designed to modulate excessive glutamate release in patients with treatment-resistant schizophrenia (TRS), a population that often has limi...