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• Clinical Study
• Product Video
• Q&A
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Product Sheet

History of Development

The following is a brief history of how GOOFICE^® was approved in Japan.



Product Characteristics

The influx of bile acids into the colon promotes defecation by two actions (Dual Action) moisture secretion and bowel movement promotion.



Mechanism of Action

This section provides an easy-to-understand explanation of the mechanism of action of GOOFICE^®

Clinical Study

Summary of Study

- Japanese Phase 3 Study
- Japanese Long-term Administration Study

Clinical Study “Spontaneous Bowel Movement Frequency”

The amount of change in the frequency of spontaneous bowel movements was superior in the GOOFICE^® group compared to the placebo group.

Complete Spontaneous Bowel Movement Frequency

Result of changes in frequency of “complete” spontaneous bowel movements.

Time to Occurrence of First Spontaneous Bowel Movement

The time to first spontaneous defecation was 5.2 hours in the GOOFICE^® group and 25.5 hours in the placebo group.

Evaluation of Stool Hardness and Severity of Constipation

Each time the subject defecated, the hardness of the stool and the degree of constipation were evaluated.

Patient Satisfaction/QOL Evaluation

Patient satisfaction with defecation.

Safety

The following is a list of adverse reaction from clinical trials in Japan.

Product Video

Q&A

• Q. GOOFICE^® is administered before meals. Why is it?

  A.

  It is to efficiently inhibit bile acid reabsorption in the intestine.
  This drug directly inhibits the transporter involved in bile acid reabsorption (IBAT) in the terminal ileum¹ (it does not move into blood to exert its effect), and inhibits reabsorption of bile acids,² thereby increasing the flow of bile acids into the large intestine.
  For this reason, it seems desirable for efficient onset of effects that this drug is administered before bile acids are released into the duodenum following stimulation with food.

  Since there is a report from healthy individuals (n=5)³ showing that bile acids are secreted under stimulation by breakfast, lunch, and dinner, it is considered that similar effects are exerted when the drug is administered before breakfast, lunch, and dinner, and the timing of administration of this drug is set to be administration before meals.

  Circadian variation in serum bile acid concentration by background

  

  【Reference】
  1） EA Pharma Co., Ltd.: In-house data (effect on bile acid transporters)
  2） EA Pharma Co., Ltd.: In-house data (effect on bile acid absorption)
  3） Schalm SW, et al. Gut 1978; 19: 1006-14

  Prepared in November 2018

• Q. Is it acceptable to take GOOFICE^® immediately before meals, after meals, between meals, at bedtime, or as needed?

  A.

  The approved dosage regimen of this drug is "oral administration once daily before meals." Administration with other dosage regimens is outside the approved dosage regimen, and there are no data on the efficacy and safety of this drug taken immediately before meals, after meals, between meals, at bedtime, or as needed.

  For efficient onset of the effects of this drug, it is desirable to administer this drug before bile acids are released into the duodenum after stimulation with meals, that is, "before meals." Therefore, the dosage regimen is specified as "administration before meals."
  The only investigation performed with the dosage regimen other than "once-daily oral administration before meals" was the investigation of the safety, pharmacokinetics, and effects of meals in the crossover study (Japanese phase 1 study)¹ of single-dose administration under fasting conditions and single-dose administration before breakfast in Japanese patients with chronic constipation.

  Excerpt from the package insert
  [Dosage and Administration]
  The usual adult dose is 10 mg of elobixibat administered orally once daily before meals. The dose may be adjusted appropriately according to symptoms; however, the maximum daily dose is 15 mg.

  Reference:
  In clinical studies for development, the drug was administered approximately 30 minutes before breakfast.

  【Reference】
  1） EA Pharma Co., Ltd.: In-house data (clinical pharmacology study in patients with chronic constipation)

  Prepared in November 2018

• Q. While GOOFICE^® is to be administered before meals, which is the best timing, before breakfast, before lunch, or before dinner? Are there any data on comparisons?

  A.

  The approved dosage regimen of this drug is “The usual adult dose is 10 mg of elobixibat administered orally once daily before meals. The dose may be adjusted appropriately according to symptoms; however, the maximum daily dose is 15 mg.” Therefore, the drug can be taken either before breakfast, before lunch, or before dinner.
  Since there is a report from healthy individuals (n=5)¹ showing that bile acids are secreted under stimulation by breakfast, lunch, and dinner, it is considered that similar effects are exerted when the drug is administered before breakfast, lunch, and dinner.

  Therefore, set a time before breakfast, lunch, or dinner considering the patient's dosing compliance, and take the drug at that time.
  Because the Japanese phase 2 study, Japanese phase 3 study, and Japanese long-term administration study were all conducted with “administration before breakfast,” there are no data on the evaluation of differences in efficacy and safety among administration before breakfast, lunch, and dinner.

  Circadian variation in serum bile acid concentration by background

  

  【Reference】
  1） Schalm SW, et al. Gut 1978; 19: 1006-14

  Prepared in November 2018

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