The new drug is an add-on to levodopa/carbidopa for Parkinson’s patients experiencing “off” episodes.
FDA cleared istradefylline (Nourianz, Kyowa Kirin) tablets as an add-on treatment to levodopa/carbidopa for Parkinson’s disease’s (PD) patients experiencing "off" episodes.
An "off" episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking.
"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, in a statement. "We are committed to helping make additional treatments for Parkinson’s disease available to patients."
“We believe that Nourianz could be an important contributor to improve treatment outcomes. We will keep working to bring the product to patients globally,” said Tomohiro Sudo, head of Kyowa Kirin’s Global Product Management Office, in a statement from the company.
The effectiveness of Nourianz in treating "off" episodes in patients with PD who are already being treated with levodopa/carbidopa was shown in 4, 12-week placebo-controlled clinical studies that included 1,143 participants.
In all of the studies, patients treated with Nourianz experienced a statistically significant decrease from baseline in daily “off” time compared to patients receiving a placebo, FDA said.
“Istradefylline is an Adenosine A2A receptor antagonist and is a novel non-dopaminergic pharmacologic approach to treating off episodes for people living with PD,” said Dr. Stuart Isaacson, MD, with the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, in the Kyowa Kirin statement. “Based on data from 4 clinical studies, istradefylline taken as an adjunct to levodopa significantly improved off time and demonstrated a well-tolerated safety profile.”
The most common adverse reactions observed in patients taking Nourianz were involuntary muscle movement (dyskinesia), dizziness, constipation, nausea, hallucination and sleeplessness (insomnia). “Patients should be monitored for development of dyskinesia or exacerbation of existing dyskinesia. If hallucinations, psychotic behavior, or impulsive/compulsive behavior occurs, a dosage reduction or stoppage of Nourianz should be considered,” FDA said.