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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 orally disintegrating tablet formulation of rimegepant, a small molecule drug developed by Pfizer, Inc. (PFE). It is being studied as an acute treatment for chronic rhinosinusitis, both with and without nasal polyps, and is also known as rimegepant 75 mg ODT.
Rimegepant ODT is being evaluated for the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps. This is an ENT (ear, nose, and throat) indication. The drug is investigational for this use and has completed a Phase 3 clinical trial in adults.
Rimegepant ODT targets CALCRL, the calcitonin receptor-like receptor, and acts as an antagonist. By blocking this receptor, the drug is designed to interfere with signaling pathways relevant to the condition being treated. The target class is antagonist, and the molecule is a small molecule.
Rimegepant ODT is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for advancing this orally disintegrating tablet formulation, also referred to as rimegepant 75 mg ODT, through clinical development for chronic rhinosinusitis.
Rimegepant ODT is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for the treatment of chronic rhinosinusitis with or without nasal polyps.
Rimegepant ODT has been studied in the Phase 3 trial NCT05248997, titled Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis. The trial was completed, enrolled 261 participants, was randomized, double-blind, and active-controlled, and was conducted in the United States.