Merck KGaA: Top-Line Results of Long-Term Study of Safinamide as Add-on Treatment to Levodopa in Advanced Parkinson’s Disease
Merck KGaA and its partner Newron Pharmaceuticals S.p.A. announced the top-line results of an 18-month, double-blind, placebo-controlled extension study (study 018) of a previously completed and reported 6-month Phase III study (study 016) of safinamide. The objective of this extension study was to assess the long-term (24-month) efficacy and safety of two doses of safinamide (50 mg and 100 mg once daily tablets) as add-on therapy to levodopa in patients with advanced Parkinson’s disease. While the primary efficacy endpoint of study 018 measuring dyskinesia after 24 months of treatment was not met, results of the exploratory analysis of the pre-specified main secondary endpoint were consistent with the effect on motor function observed in study 016. Results from the study also further support the safety profile of safinamide.
The primary efficacy endpoint of study 018 was the mean change in the ratings of the Dyskinesia Rating Scale1 (DRS). After 24 months, non-statistically significant mean improvements of 0.19 and 0.28 in the DRS score were observed in patients who received safinamide 50 mg and 100 mg respectively, versus a worsening of 0.32 for the placebo group (respectively p=0.21 and p=0.15 versus placebo). Dyskinesia, which consists of involuntary and twisting movements of the face and body, is a major complication of levodopa therapy, resulting in a significant deterioration of patient quality of life. At baseline, 32% of patients showed troublesome dyskinesia.
Out of the 544 patients enrolled in the extension study 81% of patients treated with safinamide completed the study (78% in the 50 mg dose group and 83% in the 100 mg dose group) compared to 81% in the placebo group. The incidences of dropouts, serious adverse events or clinically notable events among both groups treated with safinamide were comparable with those in the placebo group over 24 months and similar to the safety profile reported in study 016.
Pre-specified secondary endpoints were analyzed in an exploratory fashion. The significant effect on “ON” 2 time without troublesome or minor dyskinesia observed in study 016 (primary endpoint) was maintained at the end of the 24-month period for both safinamide doses (1.01 and 1.18 hours for the 50 mg and 100 mg dose groups respectively versus 0.34 hours for the placebo group; p=0.0031 and p=0.0002 for the 50 mg and 100 mg dose groups respectively versus placebo).
“These long-term treatment results are encouraging because they confirm the safety profile of safinamide and its effect on motor function observed in the six-month study in this advanced Parkinson’s disease population,” said Dr. Bernhard Kirschbaum, head of Global Research and Development at the Merck Serono division. “The effect of safinamide on dyskinesia will be further explored in an ongoing dedicated pilot study.”
“These results in such a rigorously controlled long-term double blind study are particularly relevant as they address key questions in terms of long-term safety and maintenance of the effect on motor function of safinamide over time,” said Luca Benatti, Newron’s CEO. “These results may offer new hope to patients with Parkinson’s disease as they need to take medications for long periods of time.”
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