{"id":2941,"date":"2019-09-20T00:00:00","date_gmt":"2021-03-18T05:41:43","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=2941"},"modified":"2021-03-18T13:41:43","modified_gmt":"2021-03-18T05:41:43","slug":"eisai-and-meiji-announce-parkinsons-disease-treatment-equfina-tablets-safinamide-mesilate-approved-in-japan","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/en\/2019\/09\/20\/eisai-and-meiji-announce-parkinsons-disease-treatment-equfina-tablets-safinamide-mesilate-approved-in-japan\/","title":{"rendered":"EISAI AND MEIJI ANNOUNCE PARKINSON\u2019S DISEASE TREATMENT EQUFINA\u00ae TABLETS (SAFINAMIDE MESILATE) APPROVED IN JAPAN"},"content":{"rendered":"

Parkinson\u2019s disease is a neurodegenerative disease which causes motor impairment, with symptoms including tremors in the limbs, muscular rigidity and shuffling gait. It is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. There are approximately 200,000 patients suffering from Parkinson\u2019s disease in Japan^{1<\/sup>, and the number of patients is increasing due to the aging of the population.^{1, 2\u00a0<\/sup>\u00a0Drugs containing levodopa are widely used to treat Parkinson\u2019s disease by replenishing the brain\u2019s supply of dopamine. However, as the disease progresses, levodopa\u2019s duration of effect (\u201con\u201d time) decreases, and there are cases where patients may experience wearing-off phenomena, a return of Parkinson\u2019s disease symptoms before the next dose. Safinamide through its main mechanism of action as a selective monoamine oxidase B (MAO-B) inhibitor, increases the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain.<\/p>\n}}

This manufacturing and marketing approval is based on a double-blind, placebo-controlled Phase II\/III study (study ME2125-3) to evaluate the efficacy and safety of safinamide as add-on therapy and an open label Phase III study (study ME2125-4) to evaluate the safety and efficacy of long-term administration of safinamide in Japanese patients with Parkinson\u2019s disease with wearing-off phenomena who are currently receiving levodopa, as well as global clinical trials.<\/p>\n

In study ME2125-3, the change in mean daily \u201con\u201d time from baseline to 24 weeks of the treatment phase, which is the primary endpoint, of treatment with safinamide 50 mg and 100 mg were statistically significant compared to placebo-controlled treatment. The most common adverse drug reactions (ADRs) \u00a0(incidence 3% and higher) observed with patients with safinamide 50 mg and 100 mg were dyskinesia and visual hallucination. Also in study ME2125-4, with regard to the change in mean daily \u201con\u201d time from baseline to 52 weeks of the treatment phase, the \u201con\u201d time with long-term administration of safinamide was extended, and showed the continued effectiveness. The most common ADRs (incidence 3% and higher) observed with patients were dyskinesia, falls, and constipation.<\/p>\n

By providing Equifina TABLETS as a new option for Parkinson\u2019s disease treatment, Eisai and Meiji will make further contributions to address the diverse needs of, and increase the benefits provided to, Parkinson\u2019s disease patients and their families.<\/p>\n

\n<\/strong><\/p>\n

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^{1<\/sup>\u00a0Japanese Society of Neurology. Treatment and Management Guideline 2018 for Parkinson\u2019s Disease
\n^{2<\/sup>\u00a0Japan Intractable Diseases Information Center\u3000http:\/\/www.nanbyou.or.jp\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"}}