Xadago (safinamide) tablets have been approved by the U.S. Food and Drug Administration as an add-on drug to treat Parkinson’s patients who take levodopa or carbidopa but have instances of increased symptoms anyway, a condition doctors call “off” episodes.
An “off” episode, when Parkinson’s medication doesn’t seem to work well, may include symptoms such as tremor and difficulty walking, the agency said in a news release.
Some 50,000 Americans are diagnosed each year with Parkinson’s, and about 1 million Americans have the neurological condition, the FDA said, citing the U.S. National Institutes of Health. Typically diagnosed in people 60 and older, it occurs when brain cells that produce the chemical dopamine become impaired or die.
The absence of enough dopamine leads to lack of smooth, purposeful movement during activities such as walking, eating, writing or shaving, the FDA said.
Xadago’s effectiveness was established in a clinical study of 645 people who were taking the Parkinson’s drug levodopa but were still having “off” periods. Compared to people who took a placebo, users of Xadago had fewer instances of Parkinson’s symptoms, without uncontrolled involuntary movements that doctors call dyskinesia.
Certain people shouldn’t take Xadago, including those with severe liver problems, who are taking a cold medication called dextromethorphan, who are taking a so-called MAOI drug or who are taking certain antidepressants, the FDA said.
Xadago’s most common side effects included involuntary movement, falls, nausea and insomnia. More serious adverse reactions included worsening high blood pressure, falling asleep during daily activities, hallucinations, psychotic behavior, compulsive behavior, fever and confusion.
The FDA granted approval of Xadago to Newron Pharmaceuticals, based in Milan, Italy.
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