Objective: This post-hoc analysis examined safinamide efficacy for providing dyskinesia-free ON time in LID patients.

Background: Safinamide has both dopaminergic and glutamate modulating activity. The latter may be of benefit in controlling levodopa-induced dyskinesia (LID) as glutamatergic overactivity is implicated in the development of LID).

Methods: The total ON time without dyskinesia and the proportion of patients with ≥1 hour ON time without dyskinesia (1 hour responders) were compared for safinamide 100 mg and placebo for a subgroup of 154 patients with baseline moderate to severe LID (scores ≥2 of the UPDRS part IV items 32 and 33), in the 6-month pivotal study SETTLE.

Results: Safinamide, compared to placebo, significantly increased ON time without dyskinesia in patients with moderate to severe dyskinesia: 1.66 hours vs 0.39 hours respectively (p=0.0110) in patients with UPDRS 32 ≥2; 2.04 hours vs 0.84 hours (p=0.0480) in patients with UPDRS 33 ≥2. The proportion of 1 hour responders was also significantly increased: 53.7% with safinamide vs 31.9% with placebo (p=0.00669) in patients with UPDRS 32 ≥2; 64.4% vs 40.4% respectively (p=0.01565) in patients with UPDRS 33 ≥2.

Conclusions: In this post-hoc analysis, safinamide increases dyskinesia-free ON time in patients with moderate to severe LID, suggesting a potential clinical benefit of its dual mechanism of action, which will be explored further.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-add-on-therapy-increases-on-time-without-dyskinesia-in-fluctuating-parkinsons-disease-pd-patients-with-moderate-to-severe-dyskinesia/