Zambon and Newron launch Xadago in Germany to treat mid- to late-stage Parkinson’s disease

Safinamide is a new chemical entity and it has 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.

Earlier, Xadago has been approved as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD therapies for mid-to late-stage fluctuating patients.

University of Dresden Neurology department chair Professor Heinz Reichmann said: "When a Parkinson’s disease patient is no longer optimally controlled with levodopa, Xadago may become the first choice as add-on to levodopa, because it has shown a balanced control of motor symptoms and motor complications.

"These benefits have been proved at six months and maintained over two years. The reason why is its unique mechanism of action, dopaminergic and non-dopaminergic targets.

"Xadago uniquely combines the modulation of the dopamine and glutamate systems, which in add-on therapy may maximize motor symptom control in Parkinson’s disease without worsening motor complications.

In due course, most Parkinson’s disease patients worldwide could benefit from the advantages of Xadago."

Earlier trials have showed that safinamide is well tolerated with a favorable side-effect profile and is easy to use: once-daily dose, no need of LD adjustment, no major drug-drug interactions, no diet restrictions due to its high MAO-B/MAO-A selectivity.

The FDA has accepted for filing the company’s new drug application (NDA) for Xadago with PDUFA date 29 December 2015.