Newron and partners to re-submit US NDA for Xadago

Italian CNS-focused drug developer Newron Pharmaceuticals (SIX: NWRN) and its partners Zambon and US WorldMeds announced today that the US Food and Drug Administration and the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the FDA no longer require Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago (safinamide).

The FDA decision was communicated during a meeting with Newron that was scheduled following the March 29, 2016 Complete Response Letter (CRL). The CRL did not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease, thus Newron will now expedite re-submission of the New Drug Application (NDA) to the FDA.

Ravi Anand, Newron’s CMO, said: “We thank the FDA and CSS for their help over the last months. Newron’s submission of additional pre-clinical abuse liability studies and additional analyses of the clinical data requested by the CSS led the FDA and CSS to conclude that no further evaluation of the abuse liability or dependence/withdrawal effects of Xadago were required. Newron and the FDA agreed on the contents of the NDA re-submission which Newron expects to complete by November of this year.”