The place of safinamide in Parkinson’s disease therapy: Focus on efficacy, safety, and treatment strategies in Russian patients

Abstract

Parkinson’s disease is a progressive neurodegenerative disorder that involves various brain structures and the peripheral autonomic nervous system, manifesting with a wide range of motor and non-motor symptoms. As the disease advances, the efficacy of levodopa in controlling motor disturbances inevitably declines, which is accompanied by the development of motor fluctuations and levodopa-induced dyskinesias. At advanced stages of Parkinson’s disease, the severity and diversity of non-motor manifestations also increase, the most common of which are pain (65–74%), fatigue (64–65%), sleep disturbances (62–63%), constipation (48%), as well as depression and apathy (39–43%). Motor fluctuations, dyskinesias, and non-motor symptoms collectively significantly impair patients’ quality of life and require timely treatment adjustment. Xadago (safinamide) is the only MAO-B inhibitor with a dual mechanism of action, combining a dopaminergic effect with a unique non-dopaminergic (antiglutamatergic) component. This article reviews the pharmacological profile of safinamide, its differences from other MAO-B inhibitors, and the results of randomized clinical trials confirming its efficacy and safety. In the 016, SETTLE, and XINDI studies, safinamide significantly increased ON-time without disabling dyskinesia and reduced OFF-time by an average of 1 hour. Furthermore, safinamide demonstrated efficacy in addressing non-motor symptoms: in the SAFINNOMOTOR study, a 38.5% reduction in the total Non-Motor Symptoms Scale (NMSS) score, a 43.6% decrease in pain intensity, as well as improvements in mood, sleep, and quality of life were observed.