Trial results for a Phase 3 study (NCT05248997) investigating rimegepant 75 mg orally disintegrating tablet for the acute treatment of chronic rhinosinusitis were posted on ClinicalTrials.gov on 2025-03-26. The study found no statistically significant difference between rimegepant and placebo across several key endpoints, including facial pain/pressure/fullness (p-value: 0.7782).
Background
Rimegepant (also known as Nurtec ODT) is an orally disintegrating tablet. This Phase 3 study investigated its use for the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.
Trial design
The study (NCT05248997) was a Phase 3, randomized, placebo-controlled trial that enrolled 261 participants. The trial aimed to compare the efficacy and safety of rimegepant 75 mg orally disintegrating tablet versus matching placebo for the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.
Key results
The trial evaluated several outcomes at 2 hours post-dose:
- Change From Baseline in Facial Pain/Pressure/Fullness on NRS:
- Rimegepant 75 mg: -2.70 scores on a scale
- Placebo: -2.61 scores on a scale
Analysis (Linear model): Difference in least square mean -0.09 (95.0% CI: -0.71 to 0.53), p-value: 0.7782.
- Change From Baseline in Total Nasal Symptom Score (TNSS):
- Rimegepant 75 mg: -7.04 scores on a scale
- Placebo: -6.74 scores on a scale
Analysis (Linear model): Difference in least square mean -0.29 (95.0% CI: -1.83 to 1.24), p-value: 0.7079.
- Change From Baseline in Nasal Obstruction (Congestion):
- Rimegepant 75 mg: -2.48 scores on a scale
- Placebo: -2.25 scores on a scale
Analysis (Linear model): Difference in least square mean -0.23 (95.0% CI: -0.81 to 0.36), p-value: 0.4398.
- Change From Baseline in Nasal Discharge:
- Rimegepant 75 mg: -1.81 scores on a scale
- Placebo: -1.85 scores on a scale
Analysis (Linear model): Difference in least square mean 0.04 (95.0% CI: -0.51 to 0.59), p-value: 0.889.
- Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose:
- Rimegepant 75 mg: 59.4%
- Placebo: 55.6%
Analysis (Mantel-Haenszel): Percentage difference 3.8% (95.0% CI: -12.1 to 19.7), p-value: 0.6412.
- Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose:
- Rimegepant 75 mg: 7.3%
- Placebo: 10.0%
Analysis (Mantel-Haenszel): Percentage difference -2.7% (95.0% CI: -10.6 to 5.2), p-value: 0.5001.
What this means
The results from this Phase 3 trial indicate that rimegepant 75 mg did not demonstrate a statistically significant improvement over placebo for the acute treatment of chronic rhinosinusitis across the measured endpoints. The observed differences in symptom scores, headache relief, and rescue medication use between the rimegepant and placebo groups were not statistically significant, as indicated by the p-values for the analyses.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05248997, titled "Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis," were posted on 2025-03-26 on clinicaltrials.gov.