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FDA Approves Safinamide (Xadago®) as an Add-on Treatment for Parkinson’s

The Parkinson’s Foundation alerts the community that the US Food and Drug Administration (FDA) has approved safinamide tablets (Xadago®) as an add-on treatment for people with Parkinson’s who are currently taking carbidopa/levodopa and experiencing “off” episodes. The FDA announced the approval on March 21.

Carbidopa/levodopa is the gold-standard therapy for Parkinson’s movement symptoms. As Parkinson’s progresses, many people experience “off” periods in which the drug wears off and movement symptoms return before the next dose. "Off" periods can be very disabling.

Strategies for coping with "off" period including adjusting the medication schedule or adding new medications. For example, existing medications such as rasagiline (Azilect®), selegiline (Eldepryl®), entacapone (Comtan®) and tolcapone (Tasmar®) are proven to reduce "off times" and increase "on time" when used alongside levodopa.

Similar to Azilect or Eldepryl, the newly-approved safinamide is an MAO-B inhibitor, but works by slightly differently in the brain. The FDA states that in two clinical trials, safinamide was shown to reduce “off” periods and increase “on” time without dyskinesia in people with Parkinson's experiencing motor fluctuations. 

“We are excited to see another option available to people with Parkinson's who seek to extend the amount of time per day they experience symptom relief," said Michael S. Okun, M.D., Medical Director, Parkinson’s Foundation. “This drug belongs to the MAO-B class of medications. There are several restrictions, so people with Parkinson’s should check with their doctors as to whether this is a reasonable option for them — either as a new medication or as a replacement to their existing MAO-B inhibitor."

The FDA lists several medications, such as others in the MAO-B class, certain classes of anti-depressants and a cough and cold medicine called dextromethorphan, which can interact with safinamide. It also lists possible side effects including high blood pressure; falling asleep during daily activities; hallucinations and psychotic behavior; compulsive behaviors; fever and confusion; and retinal pathology.

Wednesday, March 22, 2017
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