FDA approves Xadago for Parkinson’s disease

The FDA has approved Xadago tablets as an add-on treatment for patients with Parkinson’s disease who are currently assigned levodopa/carbidopa and experiencing “off” episodes, according to a press release.

The agency defined an “off” episode as when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” Eric Bastings, MD, deputy director, division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

According to the FDA, the efficacy of Xadago (safinamide, Newron Pharmaceuticals) was shown in a clinical trial of 645 participants who were also assigned levodopa and were experiencing “off” time. Those assigned safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled dyskinesia, compared with those receiving a placebo. As opposed to before treatment, these patients also experienced less “off” time and had improved motor function scores, the FDA stated.

The agency also stated that in a clinical trial of 549 participants, those who added safinamide to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared with those assigned a placebo, and had better scores on a measure of motor function assessed during “on” time than before treatment.

According to the FDA, patients who have severe liver problems, take dextromethorphan, monoamine oxidase inhibitors, opioid drugs, St. John’s wort, cyclobenzaprine and antidepressants such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics and triazolopyridines should not take safinamide.

The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep, the agency stated.

Disclosure: Bastings reports no relevant financial disclosures.