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Safinamide: First Global Approval

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Abstract

Safinamide (Xadago®) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson’s disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

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References

  1. Schapira AHV. Monoamine oxidase B inhibitors for the treatment of Parkinson’s disease: a review of symptomatic and potential disease-modifying effects. CNS Drugs. 2011;25:1061–71.

    Article  CAS  PubMed  Google Scholar 

  2. Grosset DG, Macphee GJ, Nairn M. Diagnosis and pharmacological management of Parkinson’s disease: summary of SIGN guidelines. BMJ. 2010;340:b5614.

    Article  CAS  PubMed  Google Scholar 

  3. Parkinson’s Disease Foundation. Treating Parkinson’s: understanding medications. 2014. http://www.pdf.org. Accessed 13 Mar 2015.

  4. AgingCare. What is “time off” and “wearing off” in Parkinson’s disease? 2015. http://www.agingcare.com. Accessed 13 Mar 2015.

  5. Fox SH. Non-dopaminergic treatments for motor control in Parkinson’s disease. Drugs. 2013;73(13):1405–15.

    Article  CAS  PubMed  Google Scholar 

  6. Kulisevsky J. Emerging role of safinamide in Parkinson’s disease therapy. Eur Neurol Rev. 2014;9(2):108–12.

    Google Scholar 

  7. Zambon S.p.A. Xadago film-coated tablets: summary of product characteristics. 2015. http://ec.europa.eu/. Accessed 10 Mar 2015.

  8. Zambon S.p.A. Parkinson’s disease (PD): EU Commission approves Xadago® (safinamide) for mid-late stage PD patients [media release]. 2015. http://www.zambongroup.com.

  9. Newron Pharmaceuticals. Safinamide new drug application (NDA) submitted to the US Food and Drug Administration (FDA). Media release. 2014. http://www.newron.com.

  10. Newron Pharmaceuticals and Zambon S.p.A. Refusal to file letter received from US FDA for safinamide, based on organization and navigation problems. Media release. 2014. http://www.newron.com.

  11. Newron Pharmaceuticals. Xadago® (safinamide) new drug application (NDA) accepted for filing by the U.S. Food and Drug Administration (FDA) [media release]. 2015. http://www.newron.com.

  12. Newron Pharmaceuticals. Safinamide new drug application (NDA) re-submitted to the US Food and Drug Administration (FDA) [media release]. 2014. http://www.newron.com.

  13. Newron Pharmaceuticals S.p.A. Newron and Zambon enter into a strategic collaboration and licence agreement for Safinamide [media release]. 2012. http://www.newron.com.

  14. Newron Pharmaceuticals S.p.A. Newron and Zambon enter into strategic collaboration and licence option for Safinamide in the EU and US [media release]. 2012. http://www.newron.com.

  15. Newron Pharmaceuticals S.p.A. Newron signs license agreement with Meiji Seika Pharma for safinamide covering Japan and key Asian territories [media release]. 2012. http://www.newron.com.

  16. Serono and Newron Pharmaceuticals S.p.A. Serono and Newron announce global development and commercialization agreement for safinamide [media release]. 2006. http://www.serono.com.

  17. Newron Pharmaceuticals S.p.A. Newron regains full global rights to safinamide from Merck Serono [media release]. 2011. http://www.newron.com.

  18. Caccia C, Maj R, Calabresi M, et al. Safinamide: from molecular targets to a new anti-Parkinson drug. Neurology. 2006;67(7 Suppl 2):S18–23.

    Article  CAS  PubMed  Google Scholar 

  19. Podurgiel SA, Collins-Praino LEA, Yohn SA, et al. Tremorolytic effects of safinamide in animal models of drug-induced parkinsonian tremor. Pharmacol Biochem Behav. 2013;105(Supplement(C)):105–11.

    Article  CAS  PubMed  Google Scholar 

  20. Gregoire L, Jourdain VA, Townsend M, et al. Safinamide reduces dyskinesias and prolongs l-DOPA antiparkinsonian effect in parkinsonian monkeys. Parkinsonism Relat Disord. 2013;19(5):508–14.

    Article  PubMed  Google Scholar 

  21. Marquet A, Kupas K, Johne A, et al. The effect of safinamide, a novel drug for Parkinson’s disease, on pressor response to oral tyramine: a randomized, double-blind, clinical trial. Clin Pharmacol Ther. 2012;92(4):450–7.

    CAS  PubMed  Google Scholar 

  22. Cattaneo C, Caccia C, Marzo A, et al. Pressor response to intravenous tyramine in healthy subjects after safinamide, a novel neuroprotectant with selective, reversible monoamine oxidase B inhibition. Clin Neuropharmacol. 2003;26(4):213–7.

    Article  CAS  PubMed  Google Scholar 

  23. Di Stefano AF, Rusca A. Pressor response to oral tyramine during co-administration with safinamide in healthy volunteers. Naunyn Schmiedebergs Arch Pharmacol. 2011;384(6):505–15.

    Article  PubMed  Google Scholar 

  24. Marzo A, Dal Bo L, Monti NC, et al. Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity. Pharmacol Res. 2004;50(1):77–85.

    Article  CAS  PubMed  Google Scholar 

  25. Leuratti C, Sardina M, Ventura P, et al. Disposition and metabolism of safinamide, a novel drug for Parkinson’s disease, in healthy male volunteers. Pharmacology. 2013;92(3–4):207–16.

    Article  CAS  PubMed  Google Scholar 

  26. Krosser S, Marquet A, Gallemann D, et al. Effects of ketoconazole treatment on the pharmacokinetics of safinamide and its plasma metabolites in healthy adult subjects. Biopharm Drug Dispos. 2012;33(9):550–9.

    Article  PubMed  Google Scholar 

  27. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord. 2014;29(2):229–37.

    Article  CAS  PubMed  Google Scholar 

  28. Anand R, Lucini V, Forrest E, et al. Early onset of efficacy of safinamide on motor fluctuations in PD patients on l-dopa and other PD medications (SETTLE study) [abstract]. Mov Disord. 2014;29(Suppl 1):608.

    Google Scholar 

  29. Borgohain R, Szasz J, Stanzione P, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease. Mov Disord. 2014;29(10):1273–80.

    Article  CAS  PubMed  Google Scholar 

  30. Stocchi F, Borgohain R, Onofrj M, et al. A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson’s disease patients. Mov Disord. 2012;27(1):106–12.

    Article  CAS  PubMed  Google Scholar 

  31. Newron Pharmaceuticals S.p.A. and Zambon S.p.A. Safinamide phase III MOTION and SETTLE study results presented at 2013 American Academy of Neurology (AAN) Annual Meeting [media release]. 2013. http://www.newron.com.

  32. Barone P, Fernandez H, Ferreira J, et al. Safinamide as an add-on therapy to a stable dose of a single dopamine agonist: results from a randomized, placebo-controlled, 24-week multicenter trial in early idiopathic Parkinson disease (PD) patients (MOTION Study) [abstract no. P01.061]. Neurology. 2013;80(Meeting Abstracts 1).

  33. Schapira AH, Stocchi F, Borgohain R, et al. Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson’s disease. Eur J Neurol. 2013;20(2):271–80.

    Article  CAS  PubMed  Google Scholar 

  34. Stocchi F, Arnold G, Onofrj M, et al. Improvement of motor function in early Parkinson disease by safinamide. Neurology. 2004;63(4):746–8.

    Article  CAS  PubMed  Google Scholar 

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Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. E. D. Deeks is a salaried employee of Adis, Springer SBM.

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  1. Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Emma D. Deeks

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  1. Emma D. Deeks
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Correspondence to Emma D. Deeks.

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This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Deeks, E.D. Safinamide: First Global Approval. Drugs 75, 705–711 (2015). https://doi.org/10.1007/s40265-015-0389-7

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