Swiss-listed drugmaker Newron has decided to suspend clinical studies on their schizophrenia drug evenamide,after the USFDA expressed concerns over the central nervous system (CNS) events observed in a recently completed trial in dogs and rats.
The FDA requested Newron to delay initiation of the proposed Phase II/III pivotal studies with evenamide prior to completing additional short-term explanatory studies in rats and human subjects to address these concerns.
Evenamide was being tested in concert with other drugs against schizophrenia.While the company reported positive preliminary results for evenamide in 2017, the FDA’s concerns now will interrupt further work on the project.The CNS events were not described in the report in detail.
The company announced that the start of the proposed phase II/III studies will therefore be suspended until after the discussion of the results of such studies with the FDA and making necessary changes in the planned pivotal studies.
“Based on the issues raised by the FDA letter, Newron is confident that they can be addressed satisfactorily”stated Ravi Anand, MD, Chief Medical Officer of Newron