Objective: The present post-hoc analysis of the results of two pivotal trials (016 and 018) investigated the effects of safinamide 100 mg/day on mood in mid- to late-stage Parkinson’s disease (PD) patients with fluctuations.

Background: Safinamide (Xadago, Zambon SpA, Italy), a new drug with an innovative dual mechanism of action (dopaminergic and non-dopaminergic) has shown to increase the ON time and decrease the OFF time without increasing troublesome dyskinesia, maintaining its efficacy up to two years, with additional benefits on quality of life and pain.

Methods: The analysis focused on outcomes related to mood: scores of the Emotional well-being domain of the Parkinson’s disease Questionnaire (PDQ)-39, scores of the GRID Hamilton Rating Scale for Depression (GRID-HAMD) and the proportion of patients reporting depression as an adverse event.

Results: Compared to placebo, safinamide 100 mg/day significantly improved the PDQ-39 emotional well-being domain and the GRID-HAMD total score in the short (6-months) and long-term (2-years). Moreover, patients in the safinamide group reported a significant lower incidence of the adverse event depression.

Conclusions: The add-on of safinamide to levodopa (alone or in combination with other PD medications) improved well-being and mood over two years in fluctuating PD patients, reducing the incidence of the adverse event depression. The favorable effect of safinamide may be explained by its modulation of glutamatergic hyperactivity through the use- and state-dependent sodium channels blockade.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-efficacy-of-safinamide-on-mood-in-parkinsonian-patients-with-fluctuations/