Comparative bioavailability of single-dose zavegepant during and between migraine attacks: A phase 1, randomized, open-label, fixed-sequence, two-period study.

ABSTRACT:

Objective

To compare the rate and extent of absorption of zavegepant 10 mg (therapeutic dose) or 20 mg (supratherapeutic dose) nasal spray during a migraine attack versus non-migraine period, assess safety, and explore efficacy and the relationship between zavegepant concentration and therapeutic response.

Background

Physiologic changes occurring during a migraine attack could affect the pharmacokinetics of treatments for migraine.

Methods

This was a Phase 1, multicenter, open-label, randomized, single-dose, two-period, fixed-sequence, comparative bioavailability study. Participants with a history of 2-8 migraine attacks per month of moderate or severe pain intensity were randomized to a single dose of zavegepant 10 or 20 mg, administered intranasally during a migrain

SUBMITTER: Bertz RJ 

PROVIDER: S-EPMC11884223 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature