BACKGROUND: Pain, a frequent non-motor symptom in Parkinson's Disease (PD), 
significantly impacts on quality of life. Safinamide is a new drug with 
dopaminergic and non-dopaminergic properties, approved in Europe as adjunct 
therapy to levodopa for the treatment of fluctuating PD patients. Results from 
two 24-month, double-blind, placebo-controlled studies demonstrated that 
safinamide has positive effects on both motor functions and quality of life in 
PD patients.
OBJECTIVE: To investigate the effects of safinamide on pain management in PD 
patients with motor fluctuations using pooled data from studies 016 and SETTLE.
METHODS: This post-hoc analysis evaluated the reduction of concomitant pain 
treatments and the changes in the scores of the items related to pain of the 
Parkinson's Disease Quality of Life Questionnaire (PDQ-39). A path analysis was 
performed in order to examine direct and indirect associations between 
safinamide and PDQ-39 pain-related items assessed after 6-months of treatment.
RESULTS: The percentage of patients with no pain treatments at the end of the 
trials was significantly lower in the safinamide group compared to the placebo 
group. Safinamide 100 mg/day significantly reduced on average the individual use 
of pain treatments by ≈24% and significantly improved two out of three PDQ-39 
pain-related items of the "Bodily discomfort" domain.Path analysis showed that 
the direct effect of safinamide on pain accounted for about 80% of the total 
effect.
CONCLUSIONS: These results suggest that safinamide may have a positive effect on 
pain, one of the most underestimated non-motor symptoms. Prospective studies are 
warranted to investigate this potential benefit.