Italian pharmaceutical company Zambon and its partner Newron Pharmaceuticals have launched Xadago (safinamide) in Portugal to treat mid-to-late stage Parkinson’s disease (PD).
The new chemical entity Safinamide, with a dopaminergic and non-dopaminergic mechanism of action (MoA), provides a balanced control of motor symptoms and complications.
The product is offered in the country as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD therapies for patients.
Zambon CEO Roberto Tascione said: “Today's launch of Xadago in Portugal is a great step forward for patients who urgently need a novel treatment option for Parkinson’s disease.
“Zambon is committed to paving the way for the development of innovative therapies for patients suffering from Parkinson’s disease and other diseases of the central nervous system, with the potential to raise the standard of care.”
Xadago is already available in Germany, Switzerland, Spain, Italy, Belgium, Denmark, Sweden, UK, Luxembourg, the Netherlands and Norway.
The US Food and Drug Administration (FDA) approved the use of Xadago to treat PD as add-on therapy to levodopa / carbidopa on 21 March this year.
Results from 24-month, double-blind controlled studies suggest that safinamide showed statistically significant effects on motor fluctuations without increasing the risk of developing dyskinesia.
Due to its high MAO-B / MAO-A selectivity, Safinamide has no diet restrictions.
Zambon has the rights to develop and commercialise the product globally, excluding Japan and other key territories.
PD affects 1% to 2% of global individuals older than 65 and its prevalence is expected to grow over the next few years due to the increase in the global population and advancements in healthcare.
Image: Immunohistochemistry for alpha-synuclein showing positive staining (brown) of an intraneural Lewy-body in the Substantia nigra in PD. Photo: courtesy of Marvin 101.