The objective of this extension study was to assess the long-term (24 month) efficacy and safety of two doses of Safinamide (50mg and 100mg once daily tablets) as add-on therapy to levodopa in patients with advanced Parkinson’s disease.
The primary efficacy endpoint of study 018 was the mean change in the ratings of the Dyskinesia Rating Scale1 (DRS).
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.
The 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 50mg and 100mg dose groups respectively versus 0.34 hours for the placebo group for the 50mg and 100mg dose groups respectively versus placebo).
Merck Serono Global Research and Development head Bernhard Kirschbaum said that the 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.
Newron CEO Luca Benatti said that the results in a 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.