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FDA Approves New Add-On Treatment for Parkinson's

FDA news release; 2017 Mar 21

Publish date:: April 11, 2017

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).

Citation:

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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