US FDA approves Xadago to treat patients with Parkinson’s disease


The US Food and Drug Administration (FDA) has approved Newron Pharmaceuticals’ Xadago (safinamide) tablets to treat patients with Parkinson’s disease.

The drug had been approved as an add-on treatment for patients who are currently taking levodopa / carbidopa and experiencing ‘off’ episodes.

FDA centre for drug evaluation and research division of neurology products deputy director Eric Bastings said: “Parkinson’s is a relentless disease without a cure.

“We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

The efficacy of these tablets in treating the disease was shown in a clinical trial of 645 participants, who were also taking levodopa and experiencing ‘off’ time.

Those receiving Xadago experienced more beneficial ‘on’ time, compared to those receiving a placebo.

As part of another clinical trial that involved 549 participants, it was found that participants adding Xadago to their levodopa treatment had more ‘on’ time, compared to those taking a placebo.

Patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan should avoid taking Xadago.

"We are committed to helping make additional treatments for Parkinson’s disease available to patients."

Additionally, patients who take the monoamine oxidase inhibitor (MAOI) medicine should also avoid Xadago as the tablet may cause a sudden severe increase in blood pressure.

Uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia) were the common adverse reactions observed in patients taking Xadago.

According to the National Institutes of Health, an estimated 50,000 Americans are diagnosed with Parkinson’s disease every year and about one million Americans have the condition.

The neurological disorder typically occurs in people older than 60.


Image: Immunohistochemistry for alpha-synuclein showing positive staining (brown) of an intraneural Lewy-body in the Substantia nigra in Parkinson's disease. Photo: courtesy of Marvin 101.