New drugs for Parkinson's disease! The third-generation powerful COMT inhibitor Ongentys (opicapone) was approved in Japan and Fosun Pharma was introduced to China!

, June 30, 2020 /

BIOON/ ONO PHARMACEUTICAL, JAPAN'S MINISTRY OF HEALTH AND LABOUR (MHLW), HAS APPROVED ONGENTYS (OPICAPONE) 25MG TABLET, A NEW, DAILY, ORAL SELECTIVE PEDIATRIC TEA PHENOL-OXYGEN-METHYL TRANSFERASE (MHLWYNE) COMT) inhibitors, combined with levodopa-carbidopa or levodopa-benserazide hydro, are used in adult patients with Parkinson's disease (PD) to improve end-of-dose movement fluctuations (efficacy reduction, wearing-off phenomenon)In April 2013, Ono Pharmaceuticals obtained exclusive rights to develop and commercialize opicapone in Japan from the Portuguese pharmaceutical company BIALJanuary 2018, Fosun Pharma obtained exclusive rights to the Chinese market for $18 million from BIAL, including a $3 million down payment and a milestone payment of up to $15 millionIn March 2019, CDE undertook a clinical application for Fosun Pharmain the European Union, Ongentys was approved in June 2016 as an adjuvant therapy for l-dopa/dopadethylase inhibitors (DDCi, such as carbidepa) for use in pD adult patients who receive these combination therapies that do not stabilize end-movement fluctuationsApril this year, Ongentys 25mg and 50mg capsules were approved by the U.SFDA as an adjuvant treatment for Patients with PD who are experiencing motion fluctuations ("OFF")It's worth noting that Ongentys is the first comT inhibitor approved by theFDA, and will provide a new treatment to extend the treatment of l-dopa/kabidobaIn the U.S., Neurocrine Biosciences plans to bring Ongentys to market later this year, and in 2017 it acquired exclusive development and commercialization rights for opicapone in the U.Sand Canada from BIALthe approval of Japan, based mainly on data from the ONO3270-02 testThe trial included a multicenter, placebo-controlled, randomized, double-blind, parallel group study and an open-label, non-control, long-term extended study in patients with Japanese Parkinson's patients who received levodopa (dopamine precursor) and a dopadeliperase inhibitor (DDCi) to treat reduced efficacyThe results showed that opicapone showed superiority at the primary endpoint (change of OFF time from baseline) compared to placeboIn addition, the results showed noof theadverse reactions of the latest concerns associated with opicapone, and that the drug was well toleratedover time, patients taking lvocyclodopa/kabidoba may begin to experience an "OFF" period between two therapeutic doses, during which time there is an increase in motor symptoms such as tremor, slow movement and difficulty walkingClinical data show that in patients with Parkinson's disease who are experiencing the "OFF" period, ongentys with a lvodopa/kabidoba can reduce the "OFF" period, while increasing the "ON" period, and without disturbing movement disordersDuring the "ON" period, the motor symptoms of people with Parkinson's disease are better controlledOngentys is a new, oral, selective, long-acting, peripheral COMT inhibitor that helps block COMT enzymes that break down levodopa, a gold standard therapy for controlling motor symptoms in patients with Parkinson's diseaseOngentys protects the l-dopa by reducing the decomposition of the l-dopa in the blood, allowing more l-dopas to reach the brain, prolongits its clinical effects and help patients achieve motor symptom controlOngentys can effectively reduce the "OFF" period of Parkinson's disease, which is administered once a day, helping to reduce the burden of medication on patients and improve patient seismopicapone chemical structure (top) and Ongentys (bottom)COMT inhibitors are the first-line drugs that are clearly recommended by current treatment guidelines in Europe, America and China to assist in the treatment of Parkinson's disease patientsOngentys' active drug ingredient opicapone, developed by BIAL, is a new, powerful third-generation COMT inhibitor that increases the clinical efficacy of l-dopa by reducing the conversion rate of l-dopa to 3-O-methyldopa, thereby increasing brain utilizationnote, inclinical trial
s, ongentys was able to significantly reduce involuntary exercise time and "OFF-ON" in patients within two hours of taking the drug compared to a placeboThe so-called Parkinson's patients "OFF-ON ( switch) phenomenon" refers to the patient in the later stageof medication symptom fluctuations, that is, the patient can maintain the normal person's functional state for a period of time after taking the drug, but after the effect of the drug will occasionally appear muscle stiffness, tremor, movement can not, lasting several minutes to 1 hour after the relief, a day may be repeated many times, the phenomenon occurs frequently and unpredictable, therefore known as "switch" phenomenon(BioValleyBioon.com) original origins: Ono Receives a Manufacturing and Marketing Approval in Japan of "Ongentys Tablets 25mg", a Peripheral COMT for The Oats of The Company's Disease Patients With Motor Flus .