ZURICH (Reuters) – Swiss-listed drugmaker Newron must delay a trial of its prospective schizophrenia medicine evenamide after the U.S. Food and Drug Administration raised concerns about central nervous system (CNS) events that have emerged in rats and dogs.
The company, whose Xadago against Parkinson’s disease is already on the market, aims to broaden its stable of approved medicines with evenamide, which it is testing in concert with other drugs against schizophrenia.
While the company reported positive preliminary results for evenamide in 2017, the FDA’s concerns now will push back work on the project as Newron seeks to understand more about the issues that emerged. It did not describe the CNS events in detail.
“The start of the proposed phase II/III 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,” Milan-based Newron said.
Newron’s chief medical officer, Ravi Anand, added that “based on the issues raised by the FDA letter, Newron is confident they can be addressed satisfactorily.” Newron’s pipeline also has prospective medicines targeting Rett syndrome and neuropathic pain.
(Reporting by John Miller; Editing by Michael Shields)