Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study
Abstract
Objective: To evaluate the safety and tolerability of zavegepant (ZAV) when used as needed for acute treatment of migraine in patients taking concomitant preventive migraine medications (anti-calcitonin gene-related peptide monoclonal antibodies [CGRP mAbs] or other select preventive migraine medications [OSPs]).
Background: People with migraine often use preventive and acute treatments concomitantly for breakthrough attacks. ZAV 10-mg nasal spray is the first intranasal, small-molecule CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults.
Methods: This was a subgroup analysis of data from a multicenter, single-arm, open-label, phase 2/3 clinical trial that assessed the safety and tolerability of ZAV for the acute treatment of migraine. Participants self-administered 1 ZAV dose/day as needed up to 8 times/month for up to 52 weeks to treat migraine attacks of any severity. Participants were categorized into five cohorts based on their current or concomitant use of preventive treatments: ZAV + CGRP mAbs, ZAV + OSPs, ZAV + CGRP mAbs or OSPs, ZAV monotherapy (ZAVmono), and the overall study population. Adverse events (AEs), clinical laboratory results, and vital signs data were evaluated and summarized descriptively.
Results: A total of 603 participants self-administered ≥1 dose of ZAV and 341 participants (56.6%) completed the study. Among the 603 ZAV-treated participants, 39 (6.5%) received ZAV + CGRP mAbs, 72 (11.9%) received…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 603 participants or records.
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