The US Food and Drug Administration has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa / carbidopa and experiencing ‘off’ episodes.
An “off” episode is a time 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,’ explained Eric Bastings, MD, Deputy Director of the Division of Neurology Products in the FDA’s Centre for Drug Evaluation and Research.
‘We are committed to helping make additional treatments for Parkinson’s disease available to patients.’
The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing ‘off’ time. Those receiving Xadago experienced more beneficial ‘on’ time – a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a 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.