FDA approves safinamide to treat Parkinson’s disease


The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.

Newron Pharmaceuticals will market safinamide under the brand name Xadago.

Part of the evidence base for approving safinamide came from two clinical trials with 645 and 549 participants who were also taking levodopa and were experiencing “off” time. Patients who were receiving safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without dyskinesia, compared with those receiving a placebo. An “off” episode is when a patient’s medications are not working sufficiently, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. The increase in “on” time occurred with a reduction in “off” time and better scores on a measure of motor function during “on” time.

The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.

In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

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