Newron delays schizophrenia drug trial after FDA raises concerns

Newron Pharmaceuticals SpA

28/05/2019 06:48

ZURICH, May 28 (Reuters) - Swiss-listed drugmaker Newron
 NWRN.S  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)
 ((J.Miller@thomsonreuters.com; +41 58 306 7734; Reuters
Messaging: j.miller.thomsonreuters.com@reuters.net))