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BEKINDA · 1 trial · 1 indication
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | BEKINDA 12 mg (Ondansetron Bimodal Release Tablets), once daily for 8 weeks |
| Group B | PLACEBO_COMPARATOR | Placebo, once daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| BEKINDA | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Male and female patients age≥18 years (with a minimum of 35% males in the study) 2. Patient meets FDA guidance and Rome III criteria for IBS-D: a. Recurrent abdominal pain or discomfort over ≥6 months, with frequency ≥3 days/month in the last 3 months associated with ≥2 o...
BEKINDA is an investigational small molecule being developed for the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D). It is a bimodal release tablet formulation of ondansetron 12 mg, studied in a Phase 2 clinical trial for this gastrointestinal condition.
BEKINDA is being developed by Redhill Biopharma Ltd., a biopharmaceutical company traded on the stock exchange under the ticker symbol RDHL. The company is conducting clinical research on this drug candidate for Irritable Bowel Syndrome With Diarrhea.
BEKINDA is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug that is not yet approved by regulatory authorities. The completed trial was a randomized, double-blind, placebo-controlled study.
BEKINDA has been studied in one clinical trial, identified as NCT02757105. This was a randomized, double-blind, placebo-controlled Phase 2 trial that enrolled 127 participants with Irritable Bowel Syndrome With Diarrhea in the United States. The trial has been completed.
BEKINDA is a bimodal release tablet formulation of ondansetron 12 mg. It is designed to deliver ondansetron in a specific release pattern for the treatment of Irritable Bowel Syndrome With Diarrhea, distinguishing it from standard ondansetron formulations used for other indications.