The USFDA has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently receiving carbidopa/levodopa 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 difficulty in walking and tremors.
Eric Bastings, M.D. and Deputy Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research said: "Parkinson is a relentless disease without a cure." "We are committed to helping make additional treatments for Parkinson’s disease available to patients."About 50,000 Americans are diagnosed with Parkinson's disease (PD) annually, according to the National Institutes of Health (NIH), and one million American citizens have the same condition.
People over the age of 60, typically experience this neurological disorder. But it can also occur earlier as the brain cells that produce dopamine dies. Dopamine helps transmit signals between the areas of the brain that produces movements - such as writing, eating, and shaving. Early symptoms of this disease are subtle and occur gradually. In some people, PD progresses more quickly than in others.
The efficacy of Xadago (safinamide) in treating PD was shown in a clinical trial of 645 participants who were also receiving levodopa and were experiencing "off" time. Those who received Xadago experienced more beneficial "on" time, a time when Parkinson’s symptoms were reduced, without troublesome uncontrolled involuntary movements (dyskinesia), compared to those receiving a placebo. The increase in "on" time was accompanied by a reduced “off” time and better scores on a measure of the motor function evaluated during "on" time before the treatment.