BEDMINSTER, N.J.--(BUSINESS WIRE)--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.”
To help patients with questions about access to NOURIANZ, Kyowa Kirin offers the Kyowa Kirin Cares program. This program can provide personalized and comprehensive support for patients and caregivers along the treatment journey as well as access and reimbursement assistance. For more information, visit https://kyowakirincares.com.
Patients and healthcare professionals with questions about NOURIANZ can visit www.NOURIANZ.com or call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737).
Please see NOURIANZ indication and Important Safety Information below.
NOURIANZ™ (istradefylline) is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.
Important Safety Information
Warnings and Precautions
Dyskinesia: NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In clinical trials, 1% of patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia, compared to 0% for placebo.
Hallucinations / Psychotic Behavior: Because of the potential risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with NOURIANZ. Consider dosage reduction or discontinuation if a patient develops hallucinations or psychotic behaviors while taking NOURIANZ.
Impulse Control / Compulsive Behaviors: Patients treated with NOURIANZ and one or more medication(s) for the treatment of Parkinson’s disease (including levodopa) may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges. In clinical trials, 1 patient treated with NOURIANZ 40 mg was reported to have impulse control disorder, compared to no patient on NOURIANZ 20 mg or placebo.
The maximum recommended dosage in patients taking strong CYP3A4 inhibitors is 20 mg once daily. Avoid use of NOURIANZ with strong CYP3A4 inducers.
Pregnancy: Based on animal data, may cause fetal harm.
Hepatic impairment: The maximum recommended dosage of NOURIANZ in patients with moderate hepatic impairment is 20 mg once daily. Avoid use in patients with severe hepatic impairment.
The most common adverse reactions with an incidence ≥5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively.
To report side effects or product complaints, call 1-800-NOURIANZ (1-800-668-7426) or call the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About Kyowa Kirin
Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. Kyowa Kirin focuses on creating new value in four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 36 group companies across North America, Europe and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs. You can learn more about the business of Kyowa Kirin at https://www.kyowakirin.com.
About NOURIANZ™ (istradefylline) tablets
NOURIANZ is an orally administered, selective adenosine A2A receptor antagonist approved in the US for adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes. The product has been marketed in Japan under the brand name NOURIAST® since May 30, 2013. In Japan, NOURIAST® is indicated for the improvement of the “wearing-off” phenomenon in patients with Parkinson’s disease on levodopa-containing preparations.
About Parkinson's disease
Parkinson’s disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement and postural instability. It is thought to be caused by progressive degeneration associated with decreased levels of dopamine in certain parts of the brain, i.e., the substantia nigra and striatum.
NOURIANZ™ and NOURIAST® are trademarks of Kyowa Kirin Co., Ltd.