Newron Pharmaceuticals Stock (OTC: NWPHF)

Latest news for Newron Pharmaceuticals (OTC:NWPHF) Stock

Newron Pharmaceuticals SpA is a biopharmaceutical company focused on the development of therapies for patients with diseases of the central and peripheral nervous system. Geographically the research and development activities are performed in Italy and the United States.

NEWRON PHARMS SPA ORD by Newron Pharmaceuticals SPA

Newron Pharmaceuticals SpA

Newron Pharmaceuticals

Newron Pharmaceuticals S.p.A. (OTC: <a class="ticker" href="/stock/nwphf#OTC">NWPHF</a>), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced today that a complete response letter from the FDA has been received for safinamide.

The complete response letter requests clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects as required by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.

Ravi Anand, MD, CMO, said: "The complete response letter does not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson's disease. Newron is requesting a meeting with the representatives of the Controlled Substance Staff and Division of Neurological Products to finalize plans for the additional experiments."

Newron and its partners will provide an update on the potential timelines for approval of safinamide in the near future.

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Tuesday, March 29, 2016

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