Phase III SETTLE trial of safinamide (Newron Pharma) shows significant improvements in Parkinson's Disease patients

Results from the SETTLE Phase III study of safinamide, from Newron Pharma, shows it significantly improved "super responder" rates in fluctuating Parkinson's Disease (PD) patients as an add-on to levodopa and other dopaminergic therapies. Safinamide was also associated with clinically important improvement in motor symptoms in fluctuating PD patients. The SETTLE study was a six-month (24-week), randomized, double-blind, placebo-controlled involving 549 patients with mid-to late-stage idiopathic PD.

Results showed improvements of more than one hour in the patient and caregiver-rated ON and OFF time plus 30 per cent or greater improvement in motor symptoms (UPDRS Part III) in a significantly larger proportion of patients than standard of care. Safinamide was very well tolerated. Results were presented at the 17th International Congress of Parkinson's disease and Movement Disorders and will be part of the regulatory submission planned to be filed in Europe and USA in QIV/2013.