FDA Okays Safinamide (Xadago) for Parkinson's Disease

Megan Brooks

Disclosures

March 21, 2017

The US Food Drug Administration (FDA) has approved safinamide tablets (Xadago, Newron Pharmaceuticals) as adjunctive treatment for patients with Parkinson's disease who experience "off" episodes while taking levodopa/carbidopa.

Safinamide is a selective monoamine oxidase (MAO) B inhibitor.

In a clinical trial of 645 patients with Parkinson's disease who were experiencing "off" time while taking levodopa, those who added safinamide experienced more "on" time than did those who added placebo. The increase in "on" time was accompanied by a reduction in "off" time and better scores on a measure of motor function assessed during "on" time than before treatment, the FDA said in a statement.

In a second clinical trial of 549 patients, those adding safinamide to their levodopa treatment had more "on" time without troublesome uncontrolled involuntary movement compared with those who added placebo. They also had better scores on a measure of motor function assessed during "on" time than before treatment.

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

According to the FDA, "serious, but less common, risks" include exacerbation of hypertension; serotonin syndrome when used with MAO inhibitors, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia and confusion; and retinal pathology.

Safinamide should not be used in patients with severe liver problems or those taking dextromethorphan, an MAO inhibitor, an opioid, St. John's wort, and certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine because it may cause life-threatening serotonin syndrome, the FDA said.

An estimated 50,000 Americans are diagnosed with Parkinson's disease each year, according to the National Institutes of Health, and about 1 million Americans have the condition.

"Parkinson's is a relentless disease without a cure," said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We are committed to helping make additional treatments for Parkinson's disease available to patients."

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