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.
Key findings of the study were:
- Upon analysis, the researchers found that zavegepant 10 mg and 20 mg is statistical superiority to placebo.
- At 2 hours, they found that the rate of pain freedom was 15.5% in the placebo group, 22.5% in the 10-mg group, and 23.1% in the 20-mg group.
- They also found that the rate of freedom from the most bothersome symptom was 33.7% in the placebo group, 41.9% in the 10-mg group, and 42.5% in the 20-mg group.
- However, they found no significant difference in the primary outcome of the 5 mg group.
- They reported that the most common (>5%) adverse events were dysgeusia (13.5%-16.1% with zavegepant vs 3.5% with placebo) and nasal discomfort (1.3%-5.2% with zavegepant vs 0.2% with placebo).
- They noted that the majority of adverse events were mild or moderate and found no signal of hepatoxicity.
The authors concluded, "Intranasal zavegepant 10 mg and 20 mg were effective for the acute treatment of migraine, with a favorable safety profile."
"Following successful end of Phase 2 interactions with FDA (clinical and non-clinical), zavegepant is advancing to Phase 3 for the acute treatment of migraine in adults," said Biohaven in a press release.
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