FDA delays Newron Pharmaceuticals’ trial into schizophrenia drug evenamide

pharmafile | May 28, 2019 | News story | Manufacturing and Production Newron Pharma, evenamide, pharma, schizophrenia 

Newron Pharmaceuticals has halted a clinical trial of its schizophrenia drug evenamide after the FDA raised concerns about reports of CNS events in rats and dogs in a recently completed study.

The US regulator asked Newron to delay its Phase 2/3 pivotal studies due to the potential implications of these findings in patients.

The trials will thus be delayed until the completion of discussions with the FDA and until the implementation of necessary changes takes place.

Dr Ravi Anand, Chief Medical Officer of Newron, said: “Based on the issues raised by the FDA letter, Newron is confident that they can be addressed satisfactorily.”

The Milan-headquartered firm reported positive preliminary results for evenamide in 2017. However the FDA are pushing back further trials as Newron seeks to understand more about the issues that emerged.The CNS events were not described in detail.

Shares in Newron were down by more than 16% on announcement of the news.

Louis Goss

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