Hold Placed on Newron Schizophrenia Trials

FDA has placed a clinical hold on Newron Pharmaceuticals’ proposed Phase 2-3 pivotal studies with evenamide for treating schizophrenia due to agency concerns about central nervous system events found during a recently completed study in rats as well as another at high doses in dogs, and the potential implication of these findings for human patients. FDA’s concerns have led it to request that Newron delay the proposed studies until completing additional short-term explanatory studies in rats and human subjects to address them, the company says.

“The start of the proposed Phase 2-3 studies will therefore be delayed until after the discussion of the results of such studies with the FDA and making necessary changes in the planned pivotal studies,” Newron says. The company says it will be asking for further feedback in a meeting with FDA shortly, and it will provide additional details and an update on evenamide afterwards.