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ZURICH: Swiss drug manufacturer Newron must postpone testing of its potential schizophrenia drug after the US Food and Drug Administration raised concerns about central nervous system (CNS) events in rats and dogs.
The company, of which Xadago against Parkinson's is already on the market, wants to expand its stock of drugs approved with Evenamide, which she is testing along with other drugs against schizophrenia.
While the company has announced preliminary positive results for Evenamide in 2017, FDA's concerns will now delay work on the project, as Newron seeks to better understand the issues that have emerged. He did not describe the CNS events in detail.
"The start of the proposed phase II / III studies will therefore be postponed to a date after the discussion of the results of such studies with the FDA and the necessary modifications to the planned pivotal studies," said Newron, based in Milan.
Ravi Anand, Newron Medical Director, added that "based on the issues raised in the FDA's letter, Newron is confident that they can be handled satisfactorily." The Newron pipeline also contains potential drugs targeting Rett syndrome and neuropathic pain.
(Report by John Miller, edited by Michael Shields)
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