FDA approves Parkinson’s add-on treatment

The US FDA has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s currently being administered levodopa/carbidopa and experiencing ‘off’ periods — a time when a patient’s medicine is not working well causing symptoms to increase.

Xadago’s efficacy at treating Parkinson’s disease has been shown in a clinical trial comprising 645 participants who were also taking levodopa and were experiencing ‘off’ periods. In the study, patients receiving Xadago experienced more beneficial ‘on’ time in comparison with those taking a placebo. The increase in ‘on’ time was also accompanied by a decrease in ‘off’ time in addition to better scores of motor function assessed during ‘on’ time than pre-treatment.

Another clinical trial of Xadago involving 549 participants found that adding Xadago to levodopa treatment resulted in more ‘on’ time without troublesome uncontrolled involuntary movement compared to those taking placebo. Also, better scores on a measure of motor function assessed during ‘on’ time than pre-treatment was found.

“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.”

Contra indications of the treatment include patients with severe liver problems, or those who take a medicine to treat a cough or cold (dextromethorphan). Additionally, patients who take monoamine oxidase inhibitor (MAOI) or those who take an opioid drug, St John’s Wort, certain antidepressants or cyclobenzaprine should not take Xadago.

FDA approval of this drug has been granted to Newron Pharmaceuticals.