Parkinson's new drug! Kirin nourianz (Istra defylline) is listed in the United States for treatment of off events

October 16, 2019 / bioin / -- Kyowa Kirin, a Japanese pharmaceutical company, recently announced the launch of the new Parkinson's drug nourianz (istradefyline tablet) in the United States The drug was approved by the U.S FDA at the end of August this year As an additional treatment of levodopa / carbidopa, it is used for adult patients with Parkinson's disease (PD) who are experiencing the "off" event The drug will provide a new non dopamine pharmacological approach to the treatment of "off" events in PD patients It is worth mentioning that in terms of us regulation, the FDA issued a complete response letter in late February 2008, refusing to approve istradefylline At the beginning of March this year, union Kirin once again submitted its application for istradefylline to the FDA, and finally won the FDA's nod The drug went through 11 years from being initially rejected to being approved In Japan, istradefylline was put on the market as early as may 2013, and its brand name is nouriast, which is suitable for Parkinson's disease patients receiving treatment with levodopa preparation, so as to improve the phenomenon of "declining off" Parkinson's disease (PD) is a chronic, progressive and neurodegenerative disease The main motor symptoms are tremor, rigidity and motor impairment at rest Non motor symptoms include cognitive and emotional disorders The disease is thought to be caused by progressive degeneration associated with decreased dopamine levels in certain parts of the brain, such as the substantia nigra and striatum At present, levodopa is the "gold standard" for the treatment of PD The proportion of patients taking levodopa is as high as 75% However, with the development of the disease over time, levodopa can not play the best role, resulting in the recurrence of PD symptoms (exercise and non exercise), these periods are called off period Off events can occur at any time of the day, usually after waking up in the morning and on a regular basis throughout the day Off event is characterized by tremor, rigidity or slow movement, which will disturb the ability of patients to carry out daily activities and cause heavy burden to patients, families and caregivers It is estimated that up to 40% - 60% of PD patients will have off events, and their frequency and severity will worsen in the course of disease progression These patients urgently need a new drug to effectively control the off event In December 2018, acorda's product inbrija (levodopa inhalation powder) was approved by the FDA of the United States for intermittent treatment of "off" events in PD patients treated with carbidopa / levodopa Inbrija is the first inhaled levodopa product approved by FDA It is a drug device combination, which is convenient for patients to handle the drug by themselves Inbrija uses acorda's proprietary arcus platform to develop levodopa dry powder formulations designed to provide accurate doses to patients' lungs In the case of oral administration, the drug will first be absorbed through the stomach and intestines and then reach the brain, so the starting process will change Inhalation therapy can enter the body through the lungs, directly to the brain, bypassing the digestive system Istradefylline is a selective adenosine A2A receptor antagonist for oral administration Adenosine is a neuromodulator widely distributed in human body Adenosine A2A receptor belongs to G protein coupled receptor In the brain, adenosine A2A receptors are found in the basal ganglia Basal ganglia plays an important role in motor control In Parkinson's disease, degeneration or abnormality of basal ganglia is found Nourianz's effectiveness in controlling "off" events in PD patients undergoing levodopa / carbidopa treatment was confirmed in four 12 week placebo-controlled clinical studies involving 1143 patients In all four studies, patients on nourianz had a significant reduction in daily "off" time relative to baseline compared to patients on placebo In the study, the most common adverse reactions in patients taking nourianz were involuntary muscle movements (dyskinesia), dizziness, constipation, nausea, hallucinations, and insomnia It should be noted that patients should be monitored for dyskinesia or aggravation of existing dyskinesia when using nourianz If hallucinations, psychotic behaviors, or impulsive / compulsive behaviors occur, consider reducing the dose or discontinuing the use of nourianz In addition, the use of nourianz during pregnancy is not recommended It is suggested that female patients with fertility potential should use contraceptives during the treatment Kyowa Kirin announcements nourianz? (istradefyline) now available in the U.S for treatment of Parkinson's disease "off" episodes