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# Newron Refiles NDA for Parkinson’s Drug
- URL: https://www.fdaweb.com/newron-refiles-nda-for-parkinsons-drug/
- Published: 2016-10-21T12:00:00.000Z
- Updated: 2026-09-14T21:41:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137141

Newron Pharmaceuticals has resubmitted an NDA for safinamide, indicated for treating patients with Parkinson’s disease. In March, FDA sent the company a Complete Response Letter, requesting “clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects” as required by CDER’s Controlled Substance Staff, according to the company. It did not require submission of any additional new data, Newron said at the time. The agency has set a user fee review target date of 3/21/2017.

Safinamide is a new chemical entity with a unique mode of action, including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels, which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over two years, according to Newron. Results from 24-month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia.