Newron Pharmaceuticals’ Xadago (safinamide) has been approved by the US Food and Drug Administration (FDA) as an add-on medication for patients with Parkinson’s disease. The drug is designed to complement levodopa/carbidopa during periods of decreased medication effectiveness and increased symptom severity, known as an “off” episode.
“Parkinson’s is a relentless disease without a cure,” said Dr. Eric Bastings, 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.”
The FDA’s decision to approve the treatment was informed by a clinical trial of Xadago involving 645 patients. All patients in the trial were taking levodopa, however they were also experiencing an “off” time with an increase in symptoms such as tremor and difficulty walking.
Patients in the trial treated with Xadago showed a reduction of Parkinson’s symptoms during their “on” time, and a reduction in the duration of “off” time, compared to a placebo. An additional clinical trial involving 549 participants, showed similar results in terms of more productive “on” times with better scores on tests of motor function.
According to statistics from the National Institutes of Health (NIH), around 50,000 people in the US are diagnosed with Parkinson’s disease every year. Currently, approximately 1 million Americans suffer from the degenerative disorder.
The disease results in the death of dopamine-producing neurons in the brain. Dopamine is involved in transmitting signals throughout the brain, and allowing the muscles to move in a controlled and coordinated manner.
Levodopa is a first-line treatment for the management of Parkinson’s disease symptoms. It is converted into dopamine in the body, and acts as a replacement for the natural dopamine lost due to cell death.
Symptoms of Parkinson’s disease generally do not develop until age 60, although some patients experience earlier-onset. The cause of Parkinson’s disease is unknown, and there is no cure for the neurological disorder.