Jul, 09 2018 15:07 JST

Source: Eisai

Eisai: Results from Two Phase 3 Clinical Trials of Chronic Constipation Treatment "GOOFICE 5mg Tablet" Published in The Lancet Gastroenterology & Hepatology


TOKYO, Jul, 09 2018 - (JCN Newswire) - Eisai Co., Ltd., Eisai's subsidiary for gastrointestinal diseases EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd. announce that results from two phase 3 clinical trials (a 2-week double-blind placebo-controlled phase 3 trial and an open-label single-arm 52-week long-term phase 3 trial) for the bile acid transporter inhibitor "GOOFICE 5mg Tablet" (nonproprietary name: elobixibat hydrate; development code: AJG533, hereinafter "elobixibat") have been published in The Lancet Gastroenterology & Hepatology(1)) a journal of The Lancet which is one of the world's most influential medical journals.

The 2-week double-blind clinical trial was a placebo-controlled, randomized, double-blind trial with 133 Japanese patients with chronic constipation. Patients were orally administered 10 mg of elobixibat or placebo once daily for 2 weeks. The elobixibat group demonstrated statistically significant improvements in the primary endpoint of change in spontaneous bowel movement(2) frequency, as well as in secondary endpoints including change in complete spontaneous bowel movement(3) frequency (the secondary endpoint), length of time between dosing and the first spontaneous bowel movement, compared to the placebo group. The major side effects were abdominal pain, diarrhea and other gastrointestinal symptoms. There were no serious side effects.

The 52-week open-label phase 3 clinical trial was a single arm trial to evaluate the efficacy and safety of long-term administration of elobixibat in 341 Japanese patients with chronic constipation. The initial dose was 10 mg once daily orally for 7 days. The dose was increased or decreased in the range of 5, 10 and 15 mg per day appropriately depending on the symptoms and given for 52 weeks. As a result, constipation-related improvements including spontaneous bowel movement frequency, complete spontaneous bowel movement frequency and stool consistency were observed as early as 1 week of administration, and the effects were maintained favorably through 52 weeks. The longer the dosing period, the higher patients' satisfaction relating to defecation tended to be. In addition, in all the JPAC-QOL(4)) scores, there were statistically significant declines(5)) compared to baseline. The major side effects were abdominal pain, diarrhea, lower abdominal pain and other gastrointestinal symptoms. A serious side effect (inguinal hernia) was observed in 1 patient.

The above clinical trial results were presented at Digestive Disease Week (DDW) 2018, June 2-5 in Washington D.C., USA.

Elobixibat was jointly developed by EA Pharma and Mochida. EA Pharma and Mochida distribute elobixibat under the same brand name "GOOFICE 5mg Tablet", respectively, in Japan. EA Pharma and Eisai jointly provide proper use information of "GOOFICE 5mg Tablet" under a co-promotion agreement.

EA Pharma, Eisai and Mochida strive to make a further contribution to improve QOL for patients with chronic constipation through maximization of the product value of "GOOFICE 5mg Tablet".

(1) Atsushi Nakajima et al. "Safety and efficacy of elobixibat for chronic constipation: results from a randomised, double-blind, placebo-controlled, phase 3 trial and an open-label, single-arm, phase 3 trial" The Lancet Gastroenterology & Hepatology; 2018; 3: 537-547
(2) Defecation that occurs without a laxative, enema or manual disimpaction
(3) Spontaneous bowel movement without a feeling of incomplete evacuation
(4) Japanese version of the Patient Assessment of Constipation Quality of Life questionnaire(PAC- QOL)
(5) Lower scores mean better quality of life

About elobixibat(Nonproprietary name: elobixibat hydrate; development code AJG533; brand name "GOOFICE 5 mg Tablet")

Elobixibat is a once-daily, orally available chronic constipation* treatment with a novel action mechanism. EA Pharma in-licensed this product from Albireo AB (Headquarters: Sweden) and obtained manufacture and marketing approval in Japan. Elobixibat inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon. Elobixibat is the world's first pharmaceutical product approved for marketing with the above action mechanism. The dual action of moisture secretion and bowel movement promotion by bile acids can facilitate defecation.
*Excluding structural disease-caused constipation

About The Lancet Gastroenterology & Herpetology

The Lancet Gastroenterology & Hepatology is a journal of The Lancet journals, focusing on the gastroenterology and hepatology. The Lancet is one of the 5 most-impacting medical journals in the world.

About EA Pharma Co., Ltd.

EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 years' history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma with a full value chain covering R&D, logistics and sales & marketing.

For more information on EA Pharma Co., Ltd., please see http://www.eapharma.co.jp/en/

About Mochida Pharmaceutical Co., Ltd.

Mochida Pharmaceutical Co., Ltd. has been committed to research and development of innovative pharmaceutical products since its establishment thereby providing distinctive medicines to the medical field. Currently, the core pharmaceutical business focuses resources on the targeted areas of cardiovascular, obstetrics and gynecology, dermatology, psychiatry and gastroenterology, while also providing medicine for intractable disease as well as generics including biosimilars, to meet medical needs.

For more information on Mochida Pharmaceutical Co., Ltd., please see http://www.mochida.co.jp/english/


About Eisai
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com


Contact:
EA Pharma Co., Ltd. 
Corporate Planning Dept.
TEL: +81(0)3-6280-9802

Mochida Pharmaceutical Co., Ltd. 
Public Relations
TEL: +81(0)3-3358-7211

Eisai Co., Ltd.
PR Department 
TEL: +81(0)3-3817-5120
Source: Eisai
Sectors: BioTech

Copyright ©2019 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Multimedia


 

Related Press Release


Eisai: Total Synthesis and Nonclinical Study Results of a Novel Anticancer Drug Candidate E7130
June 18 2019 12:32 JST
 
Eisai to Present Latest Data on Perampanel at 33rd International Epilepsy Congress
June 18 2019 12:11 JST
 
Eisai to Present Latest Data on Lemborexant including Integrated Analysis of Phase III Clinical Studies at 33rd Annual Sleep Meeting
May 29 2019 09:05 JST
 
"Science Based Targets (SBT) Initiative" Approves Eisai's Greenhouse Gas Reduction Targets
May 17 2019 15:34 JST
 
Eisai to Present Data on Oncology Pipeline and Products at 55th Asco Annual Meeting
May 16 2019 07:37 JST
 
Eisai Enters Into Licensing Agreement With Medac Concerning Anti-Rheumatic Agent Methotrexate Subcutaneous Injection in Japan
May 10 2019 12:34 JST
 
Eisai: Alzheimer's Clinical Trials Consortium Selects Elenbecestat and BAN2401
May 10 2019 11:55 JST
 
Eisai and Allm Enter Into Capital and Business Alliance Agreement for ICT Healthcare Solutions
May 09 2019 11:33 JST
 
Eisai Commences Venture Investment Business Aimed at Accelerating Innovation in Drug Creation and Establishment of Ecosystem Platform
May 09 2019 11:06 JST
 
Eisai and UK Dementia Research Institute Jointly Launch New Post-Doctoral Programme to Accelerate Dementia Research
May 08 2019 08:37 JST
 
More Press release >>

Latest Press Release


More Latest Release >>