FDA Approves Add-On Treatment for Parkinson Disease

The FDA has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson disease who are currently taking levodopa/carbidopa and experiencing “off” episodes (times in which medications are not working well, allowing for increased Parkinson symptoms).

The efficacy of Xadago was evaluated in a clinical trial of 645 participants who were taking levodopa and experiencing “off” times. Those assigned to take Xadago experienced more “on” time and a reduction in “off” time, as well as better scores on a test of motor function during “on” times.
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In a second clinical trial of 549 participants, those individuals who added Xadago to levodopa experienced more “on” time without involuntary movement compared with those taking placebo, and had better scores in measurements of motor function during “on” time.

Xadago should not be taken by patients with severe liver problems, or individuals taking a dextromethorphan or monoamine oxidase inhibitor.

The most common adverse events were uncontrolled involuntary movement, falls, nausea, and insomnia.

—Michael Potts

Reference:

FDA approves drug to treat Parkinson's disease [press release]. Newron Pharmaceuticals. SILVER SPRING, Maryland, March 21, 2017. http://www.prnewswire.com/news-releases/fda-approves-drug-to-treat-parkinsons-disease-300427200.html.