BioCentury
ARTICLE | Clinical News

Xadago regulatory update

March 23, 2017 8:53 PM UTC

FDA approved an NDA for Xadago safinamide from Newron as an add-on treatment for patients with Parkinson's disease (PD) who are currently taking levodopa/carbidopa and experiencing "off" episodes. In March 2016, FDA issued a complete response letter for the therapy. Newron said the agency requested clinical evaluation of Xadago's potential effects on behaviors relating to abuse liability and its dependence and withdrawal effects. The company re-submitted the application in September (see BioCentury, April 4, 2016 & Oct. 31, 2016). The product is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B (MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity...