Nourianz FDA approval : The US Food and Drug Administration (FDA) has cleared Kyowa Kirin’s Nourianz (istradefylline) for adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.
Orally administered Nourianz is claimed to be the first and only Adenosine A2A receptor antagonist for use in Parkinson’s disease in the US.
Nourianz FDA approval was based on successful results from randomized, multi-center, double-blind, placebo-controlled trials in patients with Parkinson’s disease taking a stable dose of levodopa/carbidopa with or without other Parkinson’s disease medications.
Jeffrey S. Humphrey – Chief Development Officer of Kyowa Kirin Pharmaceutical Development, commenting on Nourianz FDA approval, said: “In clinical studies, istradefylline, used as adjunctive treatment to levodopa/carbidopa in adult patients with PD experiencing ‘OFF’ episodes, was associated with a decrease in OFF Time and increase in ON Time without troublesome dyskinesia.”
The common adverse reactions associated with Nourianz include dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia.
Pregnant women are warned not to use the drug based on animal data.
Commenting on Nourianz FDA approval, Dr Stuart Isaacson – director at Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida 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.
“Based on data from four clinical studies, istradefylline taken as an adjunct to levodopa significantly improved OFF time and demonstrated a well-tolerated safety profile.
“Istradefylline represents an important new treatment option for patients with Parkinson’s disease who experience ‘OFF’ episodes.”
Since May 2013, the product has been marketed in Japan under the brand name Nouriast for the improvement of the “wearing-off” phenomenon in patients with Parkinson’s disease on levodopa-containing preparations.
Parkinson’s disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement and postural instability.
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