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MD-7246 · 1 trial · 1 indication
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.
A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with \< 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.
| Arm | Type | Description |
|---|---|---|
| MD-7246 300 μg | EXPERIMENTAL | 1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets |
| MD-7246 600 μg | EXPERIMENTAL | 2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets |
| MD-7246 1200 μg | EXPERIMENTAL | 4 MD-7246 300-μg oral tablets |
| Placebo | PLACEBO_COMPARATOR | 4 matching placebo oral tablets |
| Name | Type | Description |
|---|---|---|
| MD-7246 | DRUG | Oral tablet |
| Placebo | DRUG | Matching oral tablet |
Inclusion Criteria: * Patient meets the Rome IV criteria for diagnosis of IBS-D * Patient maintains a minimum level of compliance with daily diary * Female patients of childbearing potential must agree to use one of the following methods of birth control: 1. Hormonal contraception 2. Double-ba...
MD-7246 is an investigational small molecule being developed for the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D). It is intended to address abdominal pain in patients with this condition. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MD-7246 is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company is conducting clinical research on this investigational drug for the gastrointestinal indication of Irritable Bowel Syndrome With Diarrhea (IBS-D).
MD-7246 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D), with a completed Phase 2 trial evaluating its effects on abdominal pain.
MD-7246 has one completed clinical trial registered under NCT03931785. This Phase 2 study, titled "A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome," enrolled 515 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.
No, MD-7246 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Irritable Bowel Syndrome With Diarrhea (IBS-D). The drug has completed a Phase 2 clinical trial, but it has not yet received regulatory approval and remains under investigation for safety and efficacy.