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Newron Pharma Delays Schizophrenia Trials Over Safety Concerns

May 28, 2019 / Mark Terry

Switzerland-based Newron Pharmaceuticals announced that it is delaying its Phase II/III clinical trials of evenamide for schizophrenia based on concerns raised by the U.S. Food and Drug Administration (FDA).The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system (CNS) events that might have implications in humans. The FDA asked the company to delay the launch of the new studies until they had completed more short-term studies in rats and humans to address the safety issues.The company expects to have a meeting soon with the agency and then provide additional updates on the drug and plans for trials. “Based on the issues raised by the FDA letter,” stated Ravid Anand, Newron’s chief medical officer, “Newron is confident that they can be addressed satisfactorily.”Evenamide is a voltage-gated sodium channel blocker. It was developed internally from the company’s proprietary ion channe...