Jul 20, 2019 | Updated: 08:54 AM EDT

‘Xadago’, Newest FDA-Approved Drug For Parkinson’s Disease

Mar 24, 2017 01:18 AM EDT

Nicole Briggs looks at a real human brain being displayed as part of new exhibition at the @Bristol attraction on March 8, 2011 in Bristol, England.
(Photo : Matt Cardy/Getty Images)

"Xadago" with the generic name Safinamide was approved by the U.S. Food and Drug Administration (FDA) as the newest treatment for Parkinson's disease. The newly approved drug is an adjuvant treatment for patients that are currently taking levodopa or carbidopa and experiencing "off" episodes. An "off" episode pertains to the time wherein the patient's current medicines are not working well causing an increase in Parkinson's symptoms such as tremor and difficulty in walking.

"Xadago" is available in tablet form and is pioneered by Zambon S.p.A, an international pharmaceutical company directed to the central nervous system and U.S FDA granted the approval to Newron Pharmaceuticals. The drug was approved on March 21 and it is the newest chemical entity approved for the treatment of Parkinson's disease in the United States over a decade.

International, randomized, clinical trials have demonstrated that "Xadago" improves both "on" time, "off" time, and Parkinsonism among patients experiencing dyskinesia and motor fluctuations while under levodopa or carbidopa, as stated by Ravi Anand, Newron's CMO. The mechanism of action of Safinamide in treating Parkinson's disease is characterized by selective MAO-B-inhibition.

According to the website of U.S. FDA, the efficacy of "Xadago" in treating Parkinson's disease was shown in a clinical trial of 645 participants who were taking levodopa experiencing "off" time. Patients receiving the drug are more beneficial "on" time without uncontrolled involuntary movement (dyskinesia). "On" time pertains to the time wherein Parkinson's symptoms are reduced.

In another clinical trial of 549 participants, those who added "Xadago" to their levodopa medication had more "on" time without dyskinesia and fluctuation of motor controls. All these findings are cross-compared to volunteers taking a placebo.

"Xadago", however, has some contraindication and precautionary measures. The newly approved drug should not be taken by patients, who have severe liver problems, and those who are under the cough and cold medication called dextromethorphan. Furthermore, it is also contraindicated in patients taking monoamine oxidase inhibitors, St. John's Wort, and certain antidepressants.

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