Post-hoc analysis of the Phase 3 trial confirms zavegepant nasal spray provides sustained pain relief and reduced functional disability over 48 hours.
48 hoursSustained pain and functional disability improvement with zavegepant nasal spray versus placebo
What the researchers found
Zavegepant 10 mg nasal spray provided sustained pain reduction and functional improvement over 48 hours versus placebo in acute migraine.
Why it matters
A nasal spray CGRP antagonist offers a non-oral, fast-acting option for migraine patients who may have nausea or gastroparesis during attacks.
The numbers in context
N=1,269 (MNAR analysis); phase 3 trial BHV3500-301; zavegepant 10 mg nasal spray vs placebo; 48-hour assessment across multiple timepoints.
How the study worked
Post-hoc analysis of Phase 3 double-blind, randomized, placebo-controlled, single-attack trial (NCT04571060).
Who was studied
Adults with >1-year migraine history
What this study cannot tell us
Post-hoc analysis — not pre-specified endpoint. Single-attack design may not reflect repeated-use outcomes.
How to read the evidence
Post-hoc analysis of a well-designed Phase 3 RCT — supportive evidence but secondary to pre-specified trial endpoints.
When this study was published
Published in 2025, providing extended outcome data for this recently approved migraine treatment.
The bigger picture
Nasal delivery expands the CGRP-targeted migraine treatment toolkit, particularly for patients who cannot take oral medications during attacks.
Questions still open
- How does nasal zavegepant compare to oral gepants for acute migraine?
- Is the nasal spray effective in patients with migraine-related nausea?
Common questions
What is zavegepant?
How fast does the nasal spray work?
Read the original research
Reduction of pain and functional disability over time in patients treated with zavegepant: a post-hoc analysis of the BHV3500-301 phase 3 randomized controlled trial.
The journal of headache and pain, 26(1), 1
Citation
Powell, Lauren; O'Sullivan, Fiona; Jayasinghe, Pramoda; Rogula, Basia; Dai, Feng; Cirillo, Jessica; Sweeney, Samantha; Abraham, Lucy; Ailani, Jessica. (2025). Reduction of pain and functional disability over time in patients treated with zavegepant: a post-hoc analysis of the BHV3500-301 phase 3 randomized controlled trial.. The journal of headache and pain, 26(1), 1. https://doi.org/10.1186/s10194-024-01915-y