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.