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.
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.