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Safinamide Phase III Study Results Presented at 2013 MDS Meeting
Date:6/18/2013

MILAN, June 19, 2013 /PRNewswire/ --


Safinamide significantly improves responder rates in fluctuating Parkinson's disease (PD) patients as add-on to levodopa

Safinamide is associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa

 

Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, presented results from SETTLE Phase III study with safinamide at the 17th International Congress of Parkinson's disease and Movement Disorders, taking place from June 16 to 20, 2013, at the Sydney Convention and Exhibition Centre, Sydney, Australia.

Results presented showed that in the SETTLE study safinamide significantly improved "super responder" rates in fluctuating PD patients as add-on to levodopa and other dopaminergic therapies. Safinamide was also associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa and other dopaminergic therapies.

Ravi Anand, Newron's CMO, stated: "The results presented indicate a magnitude of benefit with safinamide which is of clinical relevance, i.e. 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, as rated by a neurologist) in a significantly (p=0.018) larger proportion of patients than standard of care. These results demonstrate that safinamide produces clinically important improvements even in the more severe patients treated with numerous drugs. Patients who improve by such magnitude in these domains can be referred to as "super responders" and have not been observed with other treatments to d
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SOURCE Newron Pharmaceuticals
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