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

    Published on July 9, 2018

    TOKYO : 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