To evaluate the safety and tolerability of zavegepant for the acute treatment of migraine in female adults.

Migraine disproportionately affects women. Zavegepant is an intranasally administered small molecule calcitonin gene-related peptide receptor antagonist for the acute treatment of migraine.

This was a phase 2/3, multicenter, open-label, long-term safety study of zavegepant 10 mg nasal spray for the acute treatment of migraine (NCT04408794). Adults with 2–8 migraine attacks of moderate or severe pain intensity per month within 3 months of the screening visit were eligible. Participants self-administered 1 dose of zavegepant 10 mg nasal spray per day as needed to treat migraine attacks of any pain intensity, up to 8 times per month, for 52 weeks. Safety endpoints included AEs (≥5% frequency), SAEs, and AEs leading to zavegepant discontinuation.

Of 603 safety-evaluable participants, 517 (85.7%) were female. AEs were reported in 403 (77.9%) female participants, with the majority being of mild or moderate intensity. There were 18 (3.5%) hepatic-related AEs and no cardiovascular or suicidality AEs reported. In female participants, 295 (57.1%) AEs were zavegepant-related. SAEs were reported in 6 (1.2%) female participants, and no SAE was considered zavegepant-related. AEs leading to zavegepant discontinuation were reported in 38 (7.4%) female participants. Zavegepant-related AEs occurring with ≥5% frequency in female participants were dysgeusia (n=199, 38.5%), nasal discomfort (n=57, 11.0%) and throat irritation (n=29, 5.6%).