FDA spurns Newron's Xadago

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

Newron said the letter requested clinical evaluation of Xadago's potential effects on behaviors relating to abuse liability, and its dependence and withdrawal effects. The company said FDA did not require additional data, studies or analyses of the therapy's efficacy or safety in PD patients. ...