Objective: To evaluate the clinical effects of safinamide, administered as add-on therapy to levodopa in fluctuating PD patients, on symptoms severity and daily living.

Background: Levodopa is the most effective treatment for PD. However, its long-term use is associated with motor complications, which may deteriorate patients’ quality of life. Patients with PD also experience many non-motor symptoms (NMS), that might be at least as debilitating as the movement disorders.[1]  Safinamide is a MAO-B inhibitor and glutamate modulator. Safinamide has been shown to reduce OFF time without worsening dyskinesia and improve some NMS, probably due to its dual dopaminergic and glutamatergic mechanism of action. [2]

Method: Studies 016 [3] and SETTLE [4] were Phase III, double-blind, parallel-groups, randomized, placebo-controlled trials. Patients were treated with safinamide or placebo as add-on therapy to levodopa (alone or with other anti-Parkinson drugs) for 24 weeks. Study 018 [5] was the double-blind extension of trial 016 up to 24 months.Data from 1309 patients in total (549 from SETTLE, 412 from 016 and 348 from 018) were analyzed to evaluate the effects of safinamide on postural instability and gait (PIGD), motor symptoms/motor fluctuations (by means of MDS-UPDRS III and MDS-UPDRS IV scales) and health-related quality of life/activities of daily living (using CGI-C and PDQ-39 summary index score).

Results: Compared to placebo, safinamide 100 mg/day significantly improved postural instability and gait, motor symptoms  and clinical fluctuations. Moreover, safinamide significantly improved patients’ quality of life and activities of daily living: about 60% of subjects improved after safinamide treatment with statistically significant changes in the CGI-C and PDQ-39 .These significant results were maintained after 24 months, thus confirming the long-lasting effect of safinamide.

Conclusion: Safinamide, administered as add-on therapy to fluctuating PD patients, significantly improved symptoms severity with a positive effect on patients’ quality of life.

References: [1]  Kulisevsky J Safinamide – a unique treatment targeting both dopaminergic and non-dopaminergic systems European Neurological Review 2016; 11(2): 101-105 [2]  Cattaneo C, Kulisevsky J, Tubazio V, Castellani P Long-term efficacy of safinamide on Parkinson’s Disease chronic pain Adv Ther 2018; 35(4): 515-522 [3]  Borgohain R, Szasz J, Stanzione P, Meshram C, Bhatt M, Chirilineau D, Stocchi F, Lucini V, Giuliani R, Forrest E, Rice P, Anand R, Study 016 Investigators Randomized trial of safinamide add-on to levodopa in Parkinson’s Disease with motor fluctuations Mov Disord. 2014; 29(2):229-37 [4]  Schapira AH, Fox SH, Hauser RA, Jankovic J, Jost WH, Kenney C, Kulisevsky J, Pahwa R, Poewe W, Anand R Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson Disease and motor fluctuations: a randomized clinical trial JAMA Neurol 2017; 74(2): 216-224 [5]  Borgohain R, Szasz J, Stanzione P, Meshram C, Bhatt MH, Chirilineau D, Stocchi F, Lucini V, Giuliani R, Forrest E, Rice P, Anand R, Study 018 Investigators Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease Mov Disord 2014; 29(10):1273-1280

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-improves-motor-symptoms-severity-and-daily-living-in-parkinsons-disease-pd-patients/