Kyowa Kirin’s Nourianz cleared for use in Parkinson’s disease in US

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.”

Nourianz FDA approval for Parkinson’s disease by Kyowa Kirin

Nourianz FDA approval for Parkinson’s disease by Kyowa Kirin. Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net

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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One Response to Kyowa Kirin’s Nourianz cleared for use in Parkinson’s disease in US

  1. I am a 51 year old female that just found out I have Motor Neuron Disease Parkinson’s about a year and half, but I have been having signs of it for years, tremors, depression, body weakness. ECT. I honestly don’t think my doctor was reading the signs because of my gender and age. A few years ago I had my shoulder lock up on me and I was sent to a P.T since x-rays didn’t show any physical damage. My shaking was getting worse and I began falling. Only when my speech became so bad that it brought concern to my dentist was Parkinson’s even considered. He phoned my doctor with his concerns about my shaking and balance problems. By this time I was forgoing shots in the back of my neck for back and neck pain to which once again I was sent to a P.T (although x-rays showed no damage) I was told I had a few spurs which were most likely causing the pain. Here I was feeling like my whole body was falling apart and doctor could not find anything wrong, maybe in was all in my head? My doctor even seemed annoyed with me and things just kept progressing and I just kept it to myself, why bother going through testing and them finding nothing? Well, it was after my second P.T called my doctor about the weakness in my legs and arms, by this time I have developed a gait in my walk and I fell more frequently. Only then did my doctor send me to a specialist and it was found that I had Parkinson’s, and that I have had it for awhile. I think because I was a woman that my signs and symptoms weren’t taken seriously and therefor left untreated for so long,I was taking pramipexole dihydrochloride three times daily, I Was on carbidopa levodopa but only lasted 90 minutes then wore off.I found that none of the current medications worked effective for me.I got tired of using those medication so I decided to apply natural herbs formula that was prescribed to me by my second P.T, i purchase the herbal formula from totalcureherbsfoundation. com, There has been huge progression ever since I start the treatment plan which will last for 15 weeks usage.all the symptoms and sign has begin to disappear .

    Carlos Benita
    September 24, 2019 at 8:08 am
    Reply

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