Newron's CMO Ravi Anand said that these data will be included in the regulatory submission planned to be filed in the US and Europe during the fourth quarter.
Data from the clinical trial, dubbed Settle, demonstrated that 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.
Safinamide, an alpha-aminoamide, is being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage PD.
These findings were presented at the 17th International Congress of Parkinson's disease and Movement Disorders being held in Sydney, Australia.
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