Trial results for a Phase 2 study evaluating rimegepant (Nurtec ODT) for pain in Irritable Bowel Syndrome (IBS) were posted on ClinicalTrials.gov on 2026-05-22. The study's primary aim was to assess efficacy on abdominal pain scores, where rimegepant showed a median change of -12 score on a scale compared to placebo's -22.6 score on a scale.
Background
The study investigated rimegepant for abdominal pain in participants with non-constipation Irritable Bowel Syndrome (IBS). IBS is a common gastrointestinal disorder characterized by abdominal pain, bloating, and changes in bowel habits.
Trial design
The Phase 2 study (NCT06221111) enrolled 39 participants with Irritable Bowel Syndrome. The primary aim was to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS. Participants received either rimegepant 75 mg or placebo.
Key results
The trial reported the following median changes:
- For Change in Abdominal Pain Scores: rimegepant showed a change of -12 score on a scale, while placebo showed a change of -22.6 score on a scale. The ANCOVA analysis yielded a p-value of 0.41.
- For Change in Bowel Movement Frequency: rimegepant showed a change of -0.2 bowel movements per day, while placebo showed a change of -0.9 bowel movements per day. The ANCOVA analysis yielded a p-value of 0.098.
- For Change in Rectal Compliance: rimegepant showed a change of 2.1 mmHg, while placebo showed a change of -0.1 mmHg. The ANCOVA analysis yielded a p-value of 0.043.
- For Change in Rectal Sensation Pain Threshold: rimegepant showed a change of 4.0 score on a scale, while placebo showed a change of 0.0 score on a scale. The ANCOVA analysis yielded a p-value of 0.041.
- For Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions: rimegepant showed a change of -23.5 score on a scale (for Gas at 24 mmHg) and -13.5 score on a scale (for Urgency at 24 mmHg). Placebo showed changes of -7 score on a scale (for Gas at 24 mmHg) and -6 score on a scale (for Urgency at 24 mmHg). The ANCOVA analysis yielded p-values of 0.021 (for Gas at 24 mmHg) and 0.019 (for Urgency at 24 mmHg).
What this means
The results of this Phase 2 study indicate that rimegepant did not demonstrate a statistically significant improvement in abdominal pain scores for participants with Irritable Bowel Syndrome, which was the stated primary aim of the study, as evidenced by a p-value of 0.41. However, the trial did report statistically significant improvements for rimegepant compared to placebo in several other measures related to rectal function and sensation. These included an increase in rectal compliance (p=0.043), an increase in rectal sensation pain threshold (p=0.041), and reductions in rectal sensation ratings in response to distensions (p=0.021 for Gas at 24 mmHg and p=0.019 for Urgency at 24 mmHg). While these findings suggest potential benefits in specific aspects of bowel sensation, the lack of significant improvement in the primary outcome of abdominal pain means that further research would be needed to establish the overall clinical utility of rimegepant for this indication.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06221111, titled "Comparison of Rimegepant and Placebo for Pain in IBS", were posted on 2026-05-22 on clinicaltrials.gov.