FDA Approves Xadago as Add-on for Parkinson’s Patients on Levodopa/Carbidopa

The U.S. Food and Drug Administration (FDA) has approved Xadago (safinamide) as an add-on therapy to increase the effectiveness of levodopa/carbidopa in Parkinson’s disease.

Xadago limits the number of  “off” episodes, or increases in symptoms, among patients on levodopa/carbidopa, clinical trials have shown.

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

Newron Pharmaceuticals‘ Xadago works by selectively and reversibly inhibiting MAO-B, a form of the enzyme MAO that can degrade several neurotransmitters. One of the transmitters is dopamine, the lack of which is associated with Parkinson’s.

By inhibiting dopamine degradation in the brain, MAO-B inhibitors help control the motor symptoms associated with reduced levels of dopamine. This type of drug can be used as a stand-alone therapy or as an add-on to improve the action of other drugs, including levodopa, a dopamine precursor.

Xadago’s approval came after two double-blind, placebo-controlled, multinational clinical trials covering more than 1,100 patients. A once-a-day dose of Xadago led to patients having significant increases in “on” time results from levodopa — that is, times when the drug worked properly and symptoms were reduced. Xadago not only decreased patients’ “off” time, but also protected them against dyskinesia, or uncontrolled involuntary movements.

In addition, researchers said, Xadago had an extended effect, helping to control patients’ motor symptoms and complications more than two years.

“International, randomized, clinical trials have demonstrated that Xadago significantly improves ON time, OFF time, and Parkinsonism compared to standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimized levodopa/carbidopa therapy,” Ravi Anand, Newron’s chief medical officer, said in a news release. “Additionally, the onset of improvement of motor fluctuations occurred early in treatment.”

The most common adverse side effects associated with Xadago were uncontrolled involuntary movement, falls, nausea, and insomnia.

But some patients should not take Xadago, the FDA cautioned. They include people with severe liver complications, those on other MAO inhibitors and those on dextromethorphan, a drug to treat cough or cold.

Xadago has been approved in the European Union since 2015. It is available in several countries there, including Italy, Spain, the United Kingon, Belgium, Denmark, Sweden, Luxembourg, the Netherlands, Norway, and Switzerland.