Kyowa Kirin, Inc. (Kyowa Kirin), an affiliate of Kyowa Kirin Co., Ltd. (TSE: 4151), announced today that NOURIANZ (istradefylline) is now available in the U.S. as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.
Over time, patients taking levodopa may begin to experience periods when PD symptoms, including motor fluctuations, re-emerge between treatment doses. These are called “off” episodes.
“We are pleased to offer patients NOURIANZ, the first and only FDA-approved adenosine A2A receptor antagonist treatment for ‘off’ time associated with PD,” said Tom Stratford, President of Kyowa Kirin USA Holdings, Inc. “NOURIANZ administered with levodopa/carbidopa therapy can help reduce ‘off’ time and increase ‘on’ time without troublesome dyskinesia.”
There are approximately 1 million people in the U.S. with PD and about 60,000 Americans are diagnosed each year. Within five years of initiating levodopa/carbidopa, approximately 50 percent of people may experience “off” episodes in which motor symptoms occur between treatment doses.
“In my clinical practice, I see patients who experience the troublesome effects of Parkinson’s disease and ‘off’ episodes that interfere with activities of daily living,” said Peter A. LeWitt, M.D., Professor of Neurology, Wayne State University School of Medicine and Director, Parkinson’s Disease and Movement Disorders Program, Henry Ford Hospital. “NOURIANZ represents an important milestone and provides U.S. patients and their caregivers with a nondopaminergic, once-a-day oral treatment option to significantly decrease the amount of ‘off’ time.”
The U.S Food and Drug Administration (FDA) approval of NOURIANZ was based on findings from randomized, multicenter, double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications. In clinical studies, use of NOURIANZ as adjunctive treatment to levodopa/carbidopa in adult patients with PD experiencing “off” episodes was associated with a decrease in “off” time and an increase in “on” time without troublesome dyskinesia. The most common adverse reactions with an incidence ≥5% and occurring more frequently than with placebo were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia.
“Options such as NOURIANZ are a step forward in treating ‘off’ episodes, which can be troublesome and isolating for people with Parkinson’s and their families,” said Rachel Dolhun, M.D., Vice President, Medical Communications at The Michael J. Fox Foundation. “We encourage patients to speak with their healthcare providers if they are experiencing ‘off’ episodes.”
Source: Company Press Release