Approval Probability
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ML Risk
rimegepant ODT · 1 trial · 1 indication
Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.
| Arm | Type | Description |
|---|---|---|
| rimegepant 75 mg ODT | ACTIVE_COMPARATOR | One dose of rimegepant 75 mg ODT |
| Matching Placebo | ACTIVE_COMPARATOR | One dose of matching placebo |
| Name | Type | Description |
|---|---|---|
| rimegepant 75 mg ODT | DRUG | One dose of rimegepant 75 mg ODT |
| Matching placebo | DRUG | One dose of matching placebo |
Inclusion Criteria: * At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit. * Subject agrees to study-required medication restrictions and the ...
Rimegepant ODT is an investigational small molecule being studied for the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps. It is an orally disintegrating tablet. The drug is currently in Phase 3 clinical development for this ENT condition.
Rimegepant ODT is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug for the acute treatment of chronic rhinosinusitis with and without nasal polyps.
Rimegepant ODT is in Phase 3 clinical development. One Phase 3 trial has been completed, with 261 participants enrolled. The drug is investigational and has not been approved for chronic rhinosinusitis.
Rimegepant ODT has one completed Phase 3 trial, NCT05248997, titled "Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis." The trial enrolled 261 adults in the United States and was randomized, double-blind, and active-controlled.
Rimegepant ODT is not FDA approved for chronic rhinosinusitis. It remains investigational and in clinical development. A Phase 3 trial has been completed, but approval status has not been established.