FDA Approves New Add-on Therapy for Parkinson Disease
The US Food and Drug Administration (FDA) has approved Nourianz (istradefylline) oral tablets as an add-on therapy to levodopa/carbidopa for adults with Parkinson disease (PD) experiencing “off” episodes—when a patient’s medication is not working well.
This approval comes after 4, 12-week placebo-controlled clinical studies showed that patients taking Nourianz had a significant decrease in daily “off” time from baseline than their counterparts taking placebo. All participants (N = 1143) had PD and were taking levodopa/carbidopa.
The most common adverse reactions included dyskinesia, dizziness, constipation, nausea, hallucination and insomnia.
“Parkinson’s disease is a debilitating condition that profoundly impacts patients' lives," said Eric Bastings, MD, acting 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.”
FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease [press release]. Silver Spring, MD: US Food and Drug Administration; August 27, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-add-drug-treat-episodes-adults-parkinsons-disease.