FDA Approves New Drug to Reduce Off Time for Parkinson Disease Medication

August 28, 2019
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

A new FDA approval allows istradefylline to be taken as an add-on with other medication to reduce the time medication does not work in Parkinson disease patients.

The US Food and Drug Administration approved istradefylline (Nourianz) tablets as an add-on treatment with levodopa/carbidopa in adult Parkinson disease patients experiencing “off” episodes, a time when medication is not working efficiently, causing symptoms like tremors or walking difficulties to increase.

“Parkinson's disease is a debilitating condition that profoundly impacts patients' lives,” Eric Bastings, MD, acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "We are committed to helping make additional treatments for Parkinson's disease available to patients."

The approval was granted to Kyowa Kirin, a Japanese-based pharmaceutical company.

The investigators tested the effectiveness of the new drug in treating “off” episodes in patients with Parkinson disease who are already treated with levodopa/carbidopa during 4, 12-week placebo-controlled clinical trials with a total of 1143 participants.

The patients in all 4 studies treated with Nourianz experienced a statistically significant decrease from baseline in daily “off” time compared to patients receiving a placebo.

Common adverse reactions included involuntary muscle movement, dizziness, constipation, nausea, hallucination, and insomnia.

There are approximately 50,000 Parkinson disease patients in the US diagnosed annually, with about 1 million currently living with the disease.