Safinamide in the treatment pathway of Parkinson\u2019s Disease: a European Delphi Consensus

Fabrizio Stocchi,Bruno Bergmans,Angelo Antonini,Wolfgang Jost,Jaime Kulisevsky,Regina Katzenschlager,Francesc Valldeoriola,Daniela Berg,K Ray Chaudhuri,Per Odin

doi:10.1038/s41531-022-00277-z

Abstract

Safinamide is a highly selective, reversible MAO B-inhibitor recently marketed in European and North American countries. To better define clinical indications regarding motor and non-motor symptoms, targeted population and safety of this compound, ten movement disorders specialists, experts in their field, convened and developed a panel of statements on: the role of glutamate in Parkinson’s disease, introduction to fluctuations, efficacy of safinamide on motor symptoms, motor complications and non-motor symptoms, quality of life, safety of safinamide and target population for use. Strong consensus was reached for all the statements on the efficacy of safinamide on motor symptoms, motor fluctuations, quality of life and safety. Among non-motor symptoms, a positive consensus was reached for the symptoms sleep/fatigue, mood, and pain while there was a lack of consensus for the statements regarding the efficacy of safinamide in improving cognition, urinary and sexual functions. The statement on orthostatic hypotension obtained a negative consensus. The consistent and large agreement reached in this Delphi panel perfectly reflects the perception of efficacy, safety and tolerability of safinamide as evident from pivotal trials and clinical practice and shows how these findings may guide movement disorders specialists in their clinical therapeutic approach. The impact of non-motor symptoms in PD is considerable, and management remains an unmet need. In this context, the ability of safinamide to impact some non-motor symptoms may represent the most promising and distinctive feature of this compound and deserves further investigations.

Highlights

Monoamine oxidase B inhibitors represent an important treatment option in the management of Parkinson’s disease (PD), both in the early and in the advanced stages of motor complications[1,2]
Among MAO-B inhibitors, safinamide has a dual-mechanism of action since it is able to inhibit (a) MAO-B, potentiating dopaminergic transmission and (b) glutamate release by blocking voltage-dependent sodium channels and modulating calcium channels[4,5]
While its efficacy in controlling motor symptoms and improving motor fluctuations is well established[9,10,11], uncertainty remains on its potential ability to control dyskinesias in the long term or to address the many nonmotor symptoms that are typical of the advanced stages of the disease

Summary

INTRODUCTION

Monoamine oxidase B inhibitors represent an important treatment option in the management of Parkinson’s disease (PD), both in the early and in the advanced stages of motor complications[1,2]. (Valeo Pharma); it was approved in 2015 as adjunctive therapy to levodopa in mid- to late-stage fluctuating patients and became commercially available in the spring of 2016. While its efficacy in controlling motor symptoms and improving motor fluctuations is well established[9,10,11], uncertainty remains on its potential ability to control dyskinesias in the long term or to address the many nonmotor symptoms that are typical of the advanced stages of the disease. We wished to identify an ideal target population and delineate the safety in different PD patient sub-populations

RESULTS

DISCUSSION

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