New drug for Parkinson's disease! The third generation of powerful COMT inhibitor Ongentys significantly improved movement fluctuations, Fosun Pharma introduced to China!

!--, 2020 // -- Neurocrine Biosciences recently presented two new post-analysis data from Ongentys Phase III clinical data at the 2020 International Parkinson's Conference on Disease and Movement Disorders (MDS) Virtual Conference.
results show that in patients with Parkinson's disease (PD) who experience movement fluctuations, the daily Ongentys capsule reduces "OFF" time and increases "ON" time when used as an add-on therapy for lon doba/carbidoba.
real-world data show that over time, movement fluctuations have increased the burden on Parkinson's patients and the health care system, with a significant increase in hospitalizations and emergency room visits.
Ongentys is a unique, once-a-day, oral, outer week, selective and reversible papyurol-oxygen-methyl transferase (COMT) inhibitor that inhibits the comtase that breaks down L-Doba, the gold standard therapy that controls motor symptoms in PD patients.
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.
Ongentys is a third-generation COMT inhibitor that improves the bio-utilization of the brain and prolongs the clinical efficacy of LONDab by reducing the conversion rate of L-doba to 3-O-methyl doba.
ongentys increased biomass by 65 percent compared to placebos.
In April 2020, Ongentys 25mg and 50mg capsules were approved by the FDA as an add-on therapy for ZOD/Kabidoba for PD patients who are experiencing movement fluctuations ("OFF" period, reduced efficacy).
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.
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.
this meeting, a summary of post-mortem, subgroup analysis data from the Phase III Study (BIPARK-1, BIPARK-2) showed that in PD patients treated with lyso-doba/carbidoba, Ongentys was 50mg compared to placebo As an add-on therapy, the "OFF" time was significantly reduced by one hour (Ongentys 50mg n=67?109.2 min vs 40.3 min (placebo, n=59) and p=0.0161).
a separate post-mortem analysis showed that in patients recently diagnosed with parkinson's disease with motor fluctuations, when used as the first COMT inhibitor as an additional therapy for lyso-doba/carbidoba, entacap Ongentys significantly increased the absolute "ON" time by 1 hour (12 ;p4 minutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Neurocrine Biosciences also provides real-world data from retrospective medical graph retrospective studies involving adults with Parkinson's disease who began to experience movement fluctuations while taking L-Doba.
310 patients reviewed, 117 (38%) had a history of motion fluctuations of 2 years.
data showed that patients with a long history of movement fluctuations (-2 years) had significantly higher frequency of emergency visits than patients with a shorter medical history (13 per cent of patients with a shorter history of treatment (13 per cent of patients with a history of sn=15? vs. 3 per cent of patients with a history of ;p exercise fluctuations of up to 2 years).
, the hospitalization rate was significantly higher in patients with a long history of movement fluctuations (15% of patients with a history of exercise fluctuations (15% of patients with a history of exercise fluctuations of 18% vs. 6% of patients with a history of exercise fluctuations.
in patients with motor fluctuations of 2 years, the average length of hospital stay was shorter than that of patients with exercise fluctuations of 2 years, but the difference was not statistically significant (0.5 vs. 1.1 days; p.gt;0.05).
Ongentys' active pharmaceutical ingredient opicapone was developed by Portuguese pharmaceutical company BIAL, and Neurocrine Biosciences acquired exclusive development and commercial rights in the United States and Canada in 2017 from BIAL.
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 carbidobas, in adult PD patients who received these combination therapies that could not stabilize end-of-dose movement fluctuations (reduced efficacy, wearing-off phenomenon).
June 2020, Ongentys 25mg tablets were approved in Japan, in combined with L-Doba-Carbidoba or L-Doba-hydrochloric acid, for use in adult patients with PD, to improve end-of-dose movement fluctuations.
April 2013, Ono Pharmaceuticals acquired the exclusive development and commercialization rights of opicapone in Japan from THE LICENSE.
opicapone chemical structured COMT inhibitors are currently recommended in Europe, the United States and china treatment guidelines to assist in the treatment of Parkinson's patients with the first-line drugs.
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.
!--/ewebeditor:page--!--ewebeditor:page-title" -- In 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.
() Origin: Neurocrine Biosciences Presents New Data Analyses Development Efficacy of FDA-approved Once-Daily ONGENTYS® (opicapone) in Patients with Parkinson's Disease at MDS Virtual Congress 2020 !--/ewebeditor:page--.