Newron Pharmaceuticals S.p.A. (Newron), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the CNS and pain, and its partners Zambon S.p.A. and US WorldMeds, LLC, announced that Newron has re-submitted the New Drug Application (NDA) for Xadago (safinamide) to the US Food and Drug Administration FDA.

As previously reported, the FDA communicated to Newron in a meeting in July that clinical studies to evaluate the potential abuse liability or dependence/withdrawal effects of Xadago were no longer required. The meeting had been scheduled following the March 29, 2016 Complete Response Letter (CRL) by the FDA. The FDA agreed that the re-submission did not require any new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease. As a class 2 resubmission, the FDA is expected to complete its review of the re-submission within 6 months of acceptance.

Safinamide is a new chemical entity with a unique mode of action, including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels, which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24 month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon has the rights to develop and commercialize Xadago globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound. The rights to develop and commercialize Xadago in the USA have been granted to US WorldMeds, by Zambon.