XADAGO (safinamide) is now available as an add-on therapy for US patients with Parkinson’s disease currently taking levodopa/carbidopa and experiencing “off” episodes. It is not known if XADAGO is effective to treat Parkinson’s disease when taken as a single medicine (monotherapy). XADAGO, a once-daily tablet, is the first New Chemical Entity approved in the USA for Parkinson’s disease-related motor fluctuations in more than a decade for the estimated one million patients currently affected by Parkinson’s disease.
According to the US Food and Drug Administration (FDA), an “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. XADAGO is an inhibitor of monoamine oxidase B (MAO-B). Inhibition of MAO-B activity, by blocking the breakdown of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.
Stuart Isaacson, director of the Boca Raton Institute for Neurodegenerative Disorders says: “The approval of XADAGO offers an important new treatment option for the Parkinson’s community. XADAGO is the first New Chemical Entity approved for the treatment of Parkinson’s disease-related motor fluctuations in the USA in over a decade. In clinical trials, patients on once-daily XADAGO demonstrated significant improvement in ‘on’ time without troublesome dyskinesia.”
The efficacy of XADAGO was shown in clinical trials with over 1100 Parkinson’s disease patients who were taking levodopa/carbidopa and experiencing “off” time. Those receiving XADAGO experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome dyskinesia, compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a physician-assessed measure of motor function performed during “on” time than before treatment.
The FDA approved XADAGO, which is under license from Zambon, a multinational specialty pharmaceutical company based in Milan, Italy. XADAGO has been available since 2015 in the EU and is now sold in 12 countries.
US WorldMeds has licensed XADAGO from partner Zambon for distribution in the USA and partnered with Newron Pharmaceuticals, a biopharmaceutical company focused on development of novel therapies for patients with diseases of the central nervous system and pain.