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FDA Approves New Add-On Treatment for Parkinson's
FDA news release; 2017 Mar 21
The US Food and Drug Administration (FDA) has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease. The FDA granted approval of Xadago to Newron Pharmaceuticals, headquartered in Bresso near Milan, Italy, with a subsidiary in Morristown, NJ.
Indications: Xadago has been approved for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is defined as when a patient’s medications are not working well, causing an increase in Parkinson symptoms, such as tremor and difficulty walking.
Dosage/administration: Patients taking Xadago should start with 50 mg administered orally once daily at the same time of day; after 2 weeks, the dose may be increased to 100 mg once daily, based on individual need and tolerability.
Adverse reactions: The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).
US Food and Drug Administration. FDA approves drug to treat Parkinson’s disease. FDA Web site. March 21, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm547852.htm. Accessed April 3, 2017.
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