2024 American Academy of Neurology Abstract Website

Objective:

To evaluate pain severity trajectories over 48-hours in subjects treating a single migraine attack with zavegepant 10mg nasal treatment (zavegepant) or placebo.

Background:

Migraine headaches consist of fluctuating degrees of pain, ranging from mild to severe. Zavegepant is the first and only FDA approved intranasal calcitonin gene-related peptide antagonist for the acute treatment of migraine. The efficacy and safety of zavegepant has been demonstrated in BHV3500-201; NCT03872453 and BHV3500-301; NCT04571060.

Design/Methods:

Eligible subjects for this post-hoc analysis were from BHV3500-301: a phase III double-blind, randomized, placebo controlled study. Subjects included adults with ≥1-year history of migraine. Pain severity data (0mins-48hrs) was measured on a 4-point Likert scale, from no to severe pain. Outcomes included the percentage of subjects by pain state and time point, and average time spent in each state across treatment arms over 48-hours. t-tests were conducted to determine differences between groups.

Results:

Among 1,269 subjects (zavegepant=623, placebo=646), pain severity distribution was similar at time 0, with all patients experiencing moderate/severe pain. No/mild pain was achieved among both groups as early as 15-minutes post-dose, but in a larger proportion of zavegepant patients (16.5% vs 8.3%). At 1-hr 45.8% of zavegepant arm were experiencing no/mild pain vs. 38.6% on placebo. The proportion of patients experiencing moderate/severe pain continued to reduce in both study arms over 48-hrs. Averaging across subjects, the mean [standard deviation] time spent with no pain/mild pain was higher for zavegepant (36.8hrs [13.9]) vs. placebo (34.0hrs [15.4]). zavegepant subjects spent significantly less time in moderate/severe pain (11.2hrs [13.9]) compared to placebo subjects (14.0hrs [15.4]), p-value=0.001.

Conclusions:

Acute treatment of a single migraine attack with nasal zavegepant was associated with an increased reduction in pain severity over 48-hours, when compared to placebo. zavegepant subjects spent more time in no/mild pain and less time in moderate/severe pain when compared with placebo.