Newron re-submits Xadago NDA

Newron Pharmaceuticals S.p.A. (SIX:NWRN) re-submitted an NDA to FDA for Parkinson's disease candidate Xadago safinamide. In March, FDA issued a complete response letter for Xadago as an add-on therapy for early and mid to late stage PD in patients who are inadequately managed on their current treatments (see BioCentury Extra, March 29).

Newron said last month that FDA will not require it to conduct clinical studies of Xadago's dependence and withdrawal effects or abuse liability. Xadago is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B ( MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity. ...