Newron to re-file Parkinson's drug in US

Newron, and partners Zambon and WorldMeds have re-filed their Parkinson’s drug Xadago (safinamide) in the US, after the regulator dropped demands for further clinical trials regarding likelihood of abuse.

The US Food and Drug Administration rejected the drug in March, saying it needed further studies to clinically evaluate the potentially abuse liability or dependence and withdrawal effects of Xadago.

But this requirement was dropped in July, and as the FDA’s rejection letter did not ask for additional new efficacy or safety data, the companies have re-filed the drug.

Italian-based, Swiss-listed Newron submitted additional pre-clinical abuse liability studies and additional analyses of existing clinical data, which led to the FDA deciding that no further evaluation was required.

The FDA is expected to complete its review of the resubmitted filing within six months of acceptance.

Rx Securities said in a note that it expects sales of $450 million in 2020, assuming late-stage use in Europe, and early and late stage use in Japan and the US.

This is not the first time that Newron has tried to get the drug approved in the US – in 2014, it had to resubmit a filing to the FDA, because of problems with its original dossier, such as “hyperlinking of tables, folders and organisation of the table of contents.”

The FDA then extended the review, because of late addition of financial disclosure information.

Already approved in Europe, 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 two 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.

Zambon has the rights to develop and market Xadago globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and market the compound. The rights to develop and markets Xadago in the USA have been granted to US WorldMeds, by Zambon.