New drug for Parkinson's disease! The third generation of powerful COMT inhibitor Ongentys (opicapone) is available in Japan and Fosun Pharma is introduced in China!

September 07, 2020 // -- Ono Pharmaceuticals recently announced the launch of ongenys (opicapone) 25mg tablets in Japan, a new, daily, oral selective pactophenol-oxygen-methyl transferase (COMT) inhibitor for Combined with levodopa-carbidopa or levodopa-benserazide hydrochloride for adult patients with Parkinson's disease (PD), end-of-dose movement fluctuations (effect reduction, wearing-off phenomenon).
Ongentys' active drug ingredient, opicapone, was developed by the Portuguese pharmaceutical company BIAL, a third-generation COMT inhibitor that increases the clinical efficacy of L-O-methedoba by reducing the conversion rate of L-O-methedoba, thereby increasing the bio-utilization of the brain.
ongentys increased biomass by 65 percent compared to placebos.
April 2013, Ono Pharmaceuticals acquired the exclusive development and commercialization rights of opicapone in Japan from THE LICENSE.
it is worth noting that in January 2018, Fosun Pharma acquired exclusive rights to the Chinese market from BIOL for $18 million, including a $3 million down payment and a milestone payment of up to $15 million.
March 2019, CDE hosted a clinical application for Fosun Pharma.
regulatory aspect, in June 2016, Ongentys was approved in the European Union as an ad-side therapy for DDCi,DDCi, such as carbidoba, in adult PD patients who received these combination therapies that could not stabilize end-of-dose movement fluctuations.
April 2020, Ongentys 25mg and 50mg capsules were approved in the United States as an ancillary therapy for ZOD/Kabidoba for patients with PD who are experiencing movement fluctuations ("OFF" period).
it's worth noting that Ongentys is the first FDA-approved daily COMT inhibitor that will provide a new treatment to extend the efficacy of L-Doba/Carbidoba.
the U.S., Ongentys was commercialized by Neurocrine Biosciences, which in 2017 granted opicapone exclusive development and commercial rights in the U.S. and Canada from BIAL.
Over time, patients taking L-Doba/Kabidoba may begin to experience an "OFF" period between treatment doses, during which parkinson's disease motor symptoms (such as tremors, slow movement and difficulty walking) increase.
clinical data show that in people with Parkinson's disease who are experiencing the "OFF" phase, Ongentys can reduce the "OFF" period by adding L-Doba/Kabidoba, while increasing the "ON" period without disturbing movement disorders.
in the "ON" period, the movement symptoms of people with Parkinson's disease are better controlled.
Ongentys is a new, oral, selective, long-acting, exophonist COMT inhibitor that helps block the breakdown of COMT enzymes in lond dopa, the gold standard therapy that controls motor symptoms in people with Parkinson's disease.
Ongentys protects L-Doba by reducing the breakdown of L-Doba in the blood, allowing more L-Doba to reach the brain, prolonging its clinical effects and helping patients control motor symptoms.
and Ongentys (bottom) COMT inhibitors are currently recommended in European, American and domestic treatment guidelines to assist in the treatment of patients with Parkinson's disease.
Ongentys is effective in reducing the "OFF" period in people with Parkinson's disease, and the drug is given once a day to help reduce the burden of medication and improve patient compliance.
clinical trials, Ongentys significantly reduced patients' involuntary exercise time and "OFF-ON" within two hours of taking the drug compared to placebos.
The so-called Parkinson's patient 'OFF-ON) phenomenon" refers to the patient in the late stage of taking the drug appears symptom fluctuations, that is, the patient after taking the drug for a period of time to maintain a normal person's functional state, but after the effect of the drug will appear irregular muscle stiffness, tremor, movement can not, last for several minutes to 1 hour after remission, the phenomenon may be repeated many times a day, the phenomenon occurs frequently and unpredictably, on the same as the switch to the power supply, so called "switch" phenomenon.
() Original origin: Launch of Ongentys Tablets 25mg, a Permity COMT Addor in Japan.