Safinamide

Drug Profile

Safinamide

Alternative Names: EMD 1195686; FCE 26743; ME2125; NW 1015; PNU 151774; PNU 151774E; Safinamide mesilate; Safinamide mesylate; Xadago; ZP-034

Latest Information Update: 13 Jan 2017

Price : $50

At a glance

  • Originator Pfizer
  • Developer Meiji Seika Pharma; Newron Pharmaceuticals; Zambon SpA
  • Class Amides; Antiepileptic drugs; Antiparkinsonians; Benzylamines; Fluorobenzenes; Neuroprotectants; Small molecules
  • Mechanism of Action Calcium channel antagonists; Dopamine uptake inhibitors; Glutamate-release-inhibitors; Monoamine oxidase B inhibitors; Sodium channel antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Parkinson's disease
  • No development reported Drug-induced dyskinesia
  • Discontinued Alzheimer's disease; Epilepsy; Restless legs syndrome

Most Recent Events

  • 10 Jan 2017 Safinamide sub-licensed to Seqirus in Australia and New Zealand
  • 21 Oct 2016 The US FDA considers the resubmitted NDA for safinamide in Parkinson's disease to be a complete Class 2 response to March 2016 Complete Response Letter
  • 21 Oct 2016 The US FDA sets PDUFA date of March 21, 2017 for NDA review for Parkinson's disease (Adjunctive treatment, Combination therapy, Early-stage disease, Mid-stage disease, Late-stage disease)
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