Parkinson's new drug! Stradefiylline applies for listing in the EU to treat off events

January 8, 2020 / BIOON / -- Kyowa Kirin, a Japanese pharmaceutical company, recently announced that the European Drug Administration (EMA) has accepted the marketing authorization application (MAA) of nourianz (istradefylline tablets), as an adjuvant therapy based on the treatment of levodopa, 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 In Japan, istradefylline has been put on the market in May 2013 Its brand name is nouriast, which is suitable for PD patients treated with levodopa preparation and improves the phenomenon of "declining off" In the United States, the drug was approved by FDA at the end of August 2019 and marketed under the brand name nourianz As an additional treatment of levodopa / carbidopa, it is used for PD adult patients undergoing "off" events It is worth mentioning that Istra defylline has experienced quite a bumpy experience in US regulation At the end of February 2008, the FDA issued a full response letter refusing to approve the drug At the beginning of March 2019, Xiehe Kirin company once again submitted its application for istradefylline to FDA, and finally won the nod of FDA The drug has been rejected for approval for 11 years 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 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 Source: Kyowa Kirin announcements marketing authorization application for istradefylline validated by European Medicines Agency