Intranasal zavegepant efficacious, safe and well-tolerated in adults with acute migraine
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Treatment with zavegepant 10 mg nasal spray was safe, well-tolerated and provided pain and symptom relief for moderate to severe migraine compared with placebo, according to a study published in The Lancet Neurology.
“During migraine attacks, most people have functional impairments, often leading to absence from or reduced productivity at work or school and limiting participation in family, social and leisure activities,” Richard B. Lipton, MD, professor and vice chair of neurology at Albert Einstein College of Medicine, and colleagues wrote.
Researchers aimed to assess the safety, efficacy and tolerability of intranasal zavegepant for acute treatment of migraine in adults by conducting a randomized, double-blind, multicenter phase 3 study at 90 academic, clinic and research locations in the United States.
They included 1,405 individuals aged 18 years or older with at least a 1-year history of migraine with or without aura, onset before age 50 years, two to eight moderate to severe migraines per month, or fewer than 15 days per month with migraine or non-migraine headache within 3 months of screening.
Participants were randomized on a 1:1 basis to 10 mg of intranasal zavegepant or placebo, which they could use to self-treat during a moderate to severe migraine. The primary outcomes of interest were pain and symptom relief 2 hours after treatment, which were evaluated in all medicated participants who experienced an attack of moderate to severe intensity at baseline. Safety was measured in those who received at least one dose of zavegepant or placebo.
According to results, 1,269 individuals were included in the efficacy analysis (zavegepant, n = 623; placebo, n = 646). Two hours after treatment, 24% of participants in the zavegepant group had pain relief compared with 15% in the placebo group, and 40% in the zavegepant group were free from their most bothersome symptom compared with 31% in the placebo group.
The most common adverse events reported in either treatment group were dysgeusia (21% in zavegepant vs. 5% in placebo), nasal discomfort (4% vs. 1%) and nausea (3% vs. 1%). No evidence of hepatotoxicity was reported with zavegepant.
“This study provides evidence to support the use of non-oral delivery of a gepant in the acute treatment of migraine,” Lipton and colleagues wrote. “Zavegepant 10 mg nasal spray might be able to fill an important and currently unmet need for a non-oral [calcitonin gene-related peptide] antagonist with reliable evidence of efficacy and safety in the acute treatment of migraine.”