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    Home > Medical News > Medical Research Articles > Wessa launches new Parkinson's disease drug Equfina 50mg tablet splicing in Japan

    Wessa launches new Parkinson's disease drug Equfina 50mg tablet splicing in Japan

    • Last Update: 2020-06-07
    • Source: Internet
    • Author: User
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    recently, Japanese drugmaker Atva announced the launch of thenew drug(http:// in JapanEqufina 50mg tablets (safinamide, safenamide)Equfina was approved in Japan in September to improve efficacy in patients with Parkinson's disease who are undergoing treatment with a http://of a drugwith theof levodopain the United States, safinamide was approved in March 2017, becoming the first new chemical entity (NCE) in the U.Smarket in more than a decade to be approved for the treatment of Parkinson's diseasesafinamide has also been approved for sale in more than a dozen European countriesin the U.Sand European markets, safinamide's brand name is Xadago, which is recommended in combination with levodopa or other Parkinson's disease drugs for advanced parkinson's treatment's approval of EqufinaEqufina is 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)2 studies were conducted in Japanese Parkinson's patients who were being treated with L-dopa but had reduced efficacy, including:(1) ME2125-3, which assessed 2 doses of Equ Fina (50mg and 100mg, once a day, treated for 24 weeks) as an additional treatment for the efficacy and safety of the average daily non-energy-inactivation time (ON-Time) from baseline to 24 weeks of treatment period(2) ME2125-4 studies assessed the efficacy and safety of two doses of Equfina (50 mg and 100 mg, 100 mg per day, treated for 52 weeks), with the main endpoint being changes in the average daily non-energy life (ON-Time) from baseline to 52 weeks of treatment (minimum second-by-average .LSM., s.C.) ON-Time refers to the time when a Parkinson's patient takes the l-dopa drug every day for a sustained optimal effect without motor disorderIn the ME2125-3 study, two doses of Equfina treatment group (50mg and 100mg) showed a statistically significant increase (50mg: 1.39 hours longer( 95% CI: CI) compared to the placebo group0.67, 2.11; p.0002;100mg: 1.66 hours longer (95% CI: 0.93, 2.39; p 0.0001)In terms of safety, the most common adverse drug reactions (incidence of 3%) in patients treated with Equfina were motor disorders and hallucinationsIn the ME2125-4 study, Equfina (50mg and 100mg) of long-term medication of ON-Time performance was extended (1.42 x 2.72 hours) and showed continued effectivenessThe most common adverse drug reactions (incidence of 3%) were motor disorders, falls and constipation
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