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Newron Pharmaceuticals and fellow Italy-headquartered partner Zambon have filed their investigational Parkinson’s disease treatment safinamide with regulators in the USA.
The submission to the US Food and Drug Administration is for safinamide as add-on therapy in early and mid-to late stage PD patients. Newron said the filing was based on “completion of activities agreed upon during meetings” with the FDA, noting that a marketing authorisation application was submitted to the European Medicines Agency in December.
Safinamide (EMD 1195686) is a candidate drug against Parkinson’s disease with multiple methods of action. In 2007, a Phase III clinical trial was started. It was scheduled to run until 2011. The compound was originally discovered at Farmitalia-Carlo Erba and developed by Newron Pharmaceuticals, which sold the rights to Merck-Serono in 2006. In October 2011 Merck-Serono announced that they would give all rights to develop the compound back to Newron.
Common adverse events in clinical trials were nausea, dizziness, tiredness, headache and backache. There was no significant difference in the occurrence of these effects between safinamide and placebo treated patients.
Methods of action
Parkinson and RLS relevant mechanisms
Safinamide is a reversible and selective monoamine oxidase B inhibitor, reducing degradation of dopamine, and a glutamate release inhibitor. It also seems to inhibit dopamine reuptake. Additionally, safinamide blocks sodium and calcium channels.
- Fariello, RG (2007). “Safinamide”. Neurotherapeutics 4 (1): 110–116. doi:10.1016/j.nurt.2006.11.011. PMID 17199024.
- Study of Safinamide in Early Parkinson’s Disease as Add-on to Dopamine Agonist (MOTION)
- Merck Returns Rights for Safinamide to Newron, 21 October 2011.
- Chazot, PL (2007). “Drug evaluation: Safinamide for the treatment of Parkinson’s disease, epilepsy and restless legs syndrome”. Current Opinion in Investigational Drugs 8 (7): 570–579. PMID 17659477.
- H. Spreitzer (14 April 2014). “Neue Wirkstoffe – Safinamid”. Österreichische Apothekerzeitung (in German) (8/2014): 30.
- Caccia, C; Maj, R; Calabresi, M; Maestroni, S; Faravelli, L; Curatolo, L; Salvati, P; Fariello, RG (2006). “Safinamide: From molecular targets to a new anti-Parkinson drug”. Neurology 67 (7 Suppl 2): S18–23. PMID 17030736.
- Merck Serono: Vielversprechende Daten zur kognitiven Wirkung von Safinamid bei Parkinson im Frühstadium.(German) 8 June 2007.
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