Parkinson's new drug! Weicai / Meiji new selective MAO-B inhibitor equfina (safinamide) is listed in Japan!

November 21, 2019 / BIOON / -- Eisai, a Japanese pharmaceutical company, recently announced the launch of a new Parkinson's disease drug, equfina 50mg tablet (safinamide) The drug was approved in Japan in September this year to improve the phenomenon of diminishing off symptoms in patients with Parkinson's disease who are being treated with a drug containing levodopa In Japan, Meiji Seika Pharma (Meiji) has the production and sales license of equfina, and Weicai exclusively sells equfina In the United States, safinamide was approved in March 2017, becoming the first new chemical entity (NCE) approved for Parkinson's disease treatment in the U.S market in more than a decade In addition, safinamide has been approved for sale in more than ten European countries In the U.S and European markets, the brand name of safinamide is xadago, which is recommended to be used in combination with levodopa or other Parkinson's disease drugs for the treatment of idiopathic Parkinson's disease in the middle and late stage The approval of equfina was based on data from a double-blind placebo-controlled phase II / III clinical study (me2125-3) and an open label phase III study (me2125-4) Two studies are undergoing L-DOPA treatment, but there is a phenomenon of diminishing off effect Phenomenon) was carried out in patients with Parkinson's disease in Japan Among them: (1) me2125-3 study evaluated the efficacy and safety of two doses of equfina (50mg and 100mg, once a day, for 24 weeks) as an additional therapy The main end point was the change of average on time from baseline to 24 weeks (2) The me2125-4 study evaluated the efficacy and safety of two doses of equfina (50mg and 100mg, once a day, 52 weeks of treatment) over a long period of time The primary end point was the change of the mean daily non disability time (on time) from baseline to 52 weeks of treatment (LSM ± SDLP) On time refers to the time when patients with Parkinson's disease take levodopa for continuous optimal effect and no movement disorder In the me2125-3 study, compared with the placebo group, the on-time of the two doses of equfina treatment group (50mg and 100mg) showed a statistically significant increase (50mg: 1.39h [95% CI: 0.67,2.11; P = 0.0002]; 100mg: 1.66h [95% CI: 0.93,2.39; P < 0.0001]) In terms of safety, the most common adverse drug reactions (incidence ≥ 3%) in patients treated with equfina are motor disorders and hallucinations In the me2125-4 study, the on-time performance of equfina (50mg and 100mg) was prolonged (1.42 ± 2.72 hours) and showed continuous effectiveness The most common adverse drug reactions (incidence ≥ 3%) were dyskinesia, falls and constipation Parkinson's disease (PD) is a neurodegenerative disease that can cause motor disorders, including limb tremor, muscle stiffness, and gait disorders The disease is caused by the degeneration of the dopamine nervous system, which leads to the lack of the neurotransmitter dopamine in the brain According to Weicai's internal estimates, there are about 300000 Parkinson's patients in Asia (excluding China and India) According to the data of the Ministry of health, labor and welfare (MHLW), there were about 163000 Parkinson's patients in Japan in 2014 In recent years, with the aging of the population, the number is steadily increasing Levodopa is the most effective and widely used drug in the treatment of Parkinson's disease The proportion of patients taking levodopa is as high as 75% Levodopa can effectively supplement the dopamine supply of the brain, but with the development of the disease, the duration of the effect of levodopa (i.e on time) will gradually shorten In some patients, Parkinson's symptoms will appear before the next dose of levodopa treatment, which is the so-called "declining off" phenomenon In order to prevent the phenomenon of wearing off, it is often necessary to combine L-dopamine with other drugs with different mechanisms of action The active component of equfina is safinamide, a new selective monoamine oxidase B (MAO-B) inhibitor, which can reduce the degradation of dopamine secreted and help maintain the dopamine concentration in the brain In addition, safinamide can also block voltage-dependent sodium channels on neurons, thus inhibiting the release of glutamate Therefore, safinamide is a novel Parkinson's disease treatment drug with both dopaminergic and non dopaminergic mechanisms Several previous global clinical studies have shown that safinamide combined with levodopa can prolong on-time and improve motor function in the treatment of advanced Parkinson's disease Safinamide was discovered and developed by Italian pharmaceutical company newron Meiji signed a license agreement with newron in 2011, and obtained the exclusive right to develop, produce and sell safinamide in Japan and other Asian countries In March 2017, Wei Cai reached the cooperation with Meiji essence, and obtained the exclusive right of safinamide in Japan and Asian countries Original source: Parkinson's distinct treatment equifina ® 50mg tables (safinamid mesilate) opened in Japan