Intranasal zavegepant Safe and Effective For Treatment of Migraine
Zavegepant is a third-generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. A recent Phase 2/3 study demonstrated that zavegepant is effective and well-tolerated in the treatment of acute migraine. The study findings were published in the journal Neurology on April 13, 2021.
Findings from a previous single ascending dose study indicated that intranasal zavegepant produced potentially therapeutic systemic exposures. Therefore, Dr Robert Croop and colleagues conducted a study to evaluate the efficacy of zavegepant compared with placebo in the acute treatment of migraine.
It was a double-blind, randomized, dose-ranging, placebo-controlled phase 2/3 study of intranasal zavegepant in 1,581 participants with acute migraine. Participants with a single attack of moderate to severe pain intensity were randomly assigned to receive either 5 mg (n=387), 10 mg(n=391)or 20 mg (n=402)zavegepant or placebo (n=401). The major outcome assessed was freedom from pain and the most bothersome symptom (MBS; i.e., photophobia, phonophobia, or nausea) at 2 hours postdose.
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