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Updated: Jun 8, 2025
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3D-Neuronavigation In Vivo Through a Patient's Brain During a Spontaneous Migraine Headache
Published on: June 2, 2014
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Comparative bioavailability of single-dose zavegepant during and between migraine attacks: A phase 1, randomized,
Richard J Bertz1, Julie L Collins2, Jennifer Madonia1
1Biohaven Pharmaceuticals Inc., New Haven, Connecticut, USA.
Headache
|November 7, 2024
Summary
Zavegepant nasal spray showed comparable absorption during migraine attacks and non-migraine periods, particularly at the 10mg dose. This migraine treatment was safe and effective, with no clear link between drug concentration and symptom relief.
Area of Science:
- Pharmacology and Therapeutics
- Neurology
- Clinical Trials
Background:
- Migraine attacks involve physiological changes that may impact drug absorption.
- Understanding these changes is crucial for optimizing migraine treatment pharmacokinetics.
Purpose of the Study:
- To compare zavegepant nasal spray absorption during migraine vs. non-migraine periods.
- To assess the safety and efficacy of zavegepant during migraine attacks.
- To explore the relationship between zavegepant concentration and treatment response.
Main Methods:
- Phase 1, randomized, open-label, comparative bioavailability study.
- Participants received single intranasal doses of zavegepant (10mg or 20mg) during migraine and non-migraine periods.
- Plasma zavegepant concentrations, safety, and efficacy outcomes were measured.
Main Results:
- Zavegepant exposure (Cmax, AUC0-inf) was comparable between migraine and non-migraine periods, especially for the 10mg dose.
- Doubling the dose from 10mg to 20mg resulted in a less-than-dose-proportional increase in exposure.
- Median time to maximum concentration (Tmax) was 0.5 hours, and zavegepant was well-tolerated and effective in relieving migraine symptoms.
Conclusions:
- Zavegepant absorption is similar during migraine attacks and non-migraine periods.
- Zavegepant 10mg and 20mg nasal sprays are safe and effective for acute migraine treatment.
- No clear correlation was observed between zavegepant concentration and efficacy outcomes.
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