MARCH 2, 2016 Carolina HenriquesBY CAROLINA HENRIQUES
and partner Newron Pharmaceuticals S.p.A. have announced the expansion of its European market by launching Xadago (safinamide) to treat mid- to late-stage Parkinson’s disease (PD) in Italy. The drug is already available in Switzerland, Germany, and Spain.
Xadago is an add-on therapy to a stable dose of L-dopa (levodopa) alone or combined with other therapies for mid- to late-stage fluctuating Parkinson’s patients. The compound is a novel chemical body with a distinctive approach, including selective, reversible MAO-B-inhibition and voltage dependent sodium channel blocking.
Clinical trials, including the study “Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease,” have established the efficacy of safinamide in controlling motor symptoms and motor complications in the short term, sustaining the effect over two years.
Parkinson’s ranks just behind Alzheimer’s disease among the most frequent chronic, progressive, neurodegenerative disorders in older people, affecting between 1 and 2 percent of people age 65 and older around the world. As this damaging disease advances, symptoms become harder to manage and early-stage patients on L-dopa – which is still the most effective treatment for Parkinson’s known to date, become easier to manage.
The challenge is that long-term treatment with L-dopa might lead to severe motor fluctuations which can be debilitating, including phases of normal functioning (on-time) and decreased functioning (off-time). Over time and after increased doses to compensate for disease progression, many patients report involuntary movements, or L-dopa Induced Dyskinesia (LID).
“Safinamide represents an important option for patients with Parkinson’s disease already treated with L-dopa alone or with other therapeutic combinations. Its dopaminergic and non-dopaminergic properties introduce a novelty within the drugs for Parkinson’s treatment,” IRCSS S. Raffaele Professor Fabrizio Stocchi said in a press release.
“Safinamide has been demonstrated to significantly increase on-time with no or non-troublesome dyskinesias in addition to an improvement of motor functions. Studies performed in patients on L-Dopa have demonstrated its efficacy in benefiting both short-term (six months) and long-term (up to 24 months) quality of life outcomes. Safinamide has been investigated in double-blind, placebo-controlled studies of up to 24 months’ duration, where it showed a good safety profile with maintenance of the clinical benefits,” Stocchi said.
The U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for Xadago by the end of March.
Zambon’s CEO, Maurizio Castorina, said, “The launch of Xadago in Italy makes us particularly proud because it is the result of Italian research excellence and a major step forward in the treatment of this progressive disease. We are committed to developing innovative therapies for patients suffering from Parkinson’s and other central nervous system diseases and we look forward to launching this new chemical entity in other European countries in the near future.”