Sep 20, 2019 16:13 JST

Source: Eisai

Eisai and Meiji Announce Parkinson's Disease Treatment Equfina Tablets (Safinamide Mesilate) Approved In Japan

TOKYO, Sep 20, 2019 - (JCN Newswire) - Eisai Co., Ltd. and Meiji Seika Pharma Co., Ltd. has announced the manufacturing and marketing approval in Japan for the indication of improvement of wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa for Equfina TABLETS (safinamide mesilate, "safinamide"), which was developed for use in the treatment of patients with Parkinson's disease was obtained. In Japan, Meiji holds the manufacturing and marketing approval for safinamide, and Eisai exclusively sells the safinamide.

Parkinson's 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's disease in Japan(1), and the number of patients is increasing due to the aging of the population.(1), (2) Drugs containing levodopa are widely used to treat Parkinson's disease by replenishing the brain's supply of dopamine. However, as the disease progresses, levodopa's duration of effect ("on" time) decreases, and there are cases where patients may experience wearing-off phenomena, a return of Parkinson's 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.

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's disease with wearing-off phenomena who are currently receiving levodopa, as well as global clinical trials.

In study ME2125-3, the change in mean daily "on" 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) (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 "on" time from baseline to 52 weeks of the treatment phase, the "on" 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.

By providing Equifina TABLETS as a new option for Parkinson's disease treatment, Eisai and Meiji will make further contributions to address the diverse needs of, and increase the benefits provided to, Parkinson's disease patients and their families.

Contact:
Eisai Co., Ltd.
Public Relations Department 
TEL: +81-(0)3-3817-5120

Meiji Seika Pharma Co., Ltd.
Public Relations
TEL: +81-(0)3-3273-5614
Source: Eisai
Sectors: Healthcare & Pharm

Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
June 02 2025 16:46 JST
 
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
May 28 2025 16:45 JST
 
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
May 21 2025 14:00 JST
 
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16 2025 16:21 JST
 
Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
April 30 2025 13:17 JST
 
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
April 18 2025 15:52 JST
 
Eisai to Divest Rights for Pariet in China to Peak Pharma
April 01 2025 12:15 JST
 
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
March 25 2025 16:28 JST
 
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
March 25 2025 11:21 JST
 
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
March 10 2025 19:24 JST
 
More Press release >>

Latest Press Release


More Latest Release >>