Efficacy and safety of rimegepant 75 mg orally disintegrating tablet for the acute treatment of chronic rhinosinusitis in adults: Results from a multicenter, randomized, placebo-controlled, phase 2/3 trial
Abstract
Calcitonin gene-related peptide (CGRP) activation could play a causal role in the pathophysiology of chronic rhinosinusitis (CRS), a long-term inflammatory disease of the nasal cavity and paranasal sinuses. This study investigated the efficacy and safety of rimegepant 75 mg orally disintegrating tablet, a CGRP receptor antagonist, versus placebo for acute treatment of CRS. This double-blind, randomized, placebo-controlled, phase 2/3 trial enrolled adults with CRS in the United States. Participants were randomized 1:1 to rimegepant or placebo stratified by the presence or absence of nasal polyps. Participants were dispensed a single dose of study drug administered when they experienced a qualifying facial pain/pressure/fullness (Numeric Rating Scale [NRS] ≥6). The primary efficacy endpoint was a change from baseline [CFB] at 2 hours post dose in the intensity of facial pain/pressure/fullness) with baseline NRS score ≥6. Secondary endpoints included a CFB at 2 hours post dose in the NRS score for nasal obstruction/congestion and nasal discharge, and Total Nasal Symptom Score (TNSS); proportion of participants reporting headache pain relief at 2 hours post dose; and proportion of participants using rescue medication within 24 hours post dose. Efficacy outcomes were evaluated using a linear model. Of 261 participants (mean age: 49.3 years) randomized to rimegepant (n = 131) or placebo (n = 130), 96 and 100 had evaluable data for efficacy analyses. No significant treatment…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 261 participants or records.
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