The US Food and Drug Administration has approved the first novel treatment option in more than a decade for patients with Parkinson’s disease experiencing ‘off’ episodes while being treated with levodopa/carbidopa.

‘Off’ episodes describe a time when a patient’s medication is not very effective, causing an increase in disease symptoms, such as tremor and difficulty walking.

Newron Pharmaceuticals, Zambon and US WorldMeds' Xadago (safinamide) is a once-daily therapy offering 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.

In clinical trials, patients taking the drug experienced more beneficial “on” time, during which symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. This increase in “on” time was also accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment, the FDA noted.

On the safety side, the most common side effects linked with the drug in clinical trials were found to be uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

“The approval of Xadago as a treatment for patients with Parkinson’s disease by the FDA represents an important milestone as it is the first new chemical entity approved for the treatment of Parkinson’s disease in the USA in over a decade,” said Dr C. Olanow, professor and chairman emeritus of the Department of Neurology and professor emeritus of the Department of Neuroscience at the Mount Sinai School of Medicine in New York City.

Zambon holds rights to develop and commercialise the drug globally, excluding Japan and other key territories where they belong to Meiji Seika. The rights to develop and commercialise Xadago in the US were granted to US WorldMeds, which partners with Newron.

Around 50,000 Americans are diagnosed with Parkinson’s disease each year. According to analysts at Edison, peak global sales of Xadago should fall between 450 million euros and 660 million euros, depending on how the drug is priced relative to Teva/Lundbeck’s Parkinson’s therapy Azilect (rasagiline).

Xadago was approved in Europe in 2015.