2023 American Academy of Neurology Abstract Website

Objective:

Evaluate the safety and tolerability of zavegepant 10 mg nasal spray in the acute treatment of migraine.

Background:

Zavegepant is the only small molecule CGRP receptor antagonist (gepant) for intranasal administration in late-stage development for the acute treatment of migraine.

Design/Methods:

This was a Phase 2/3, 1-year open-label safety study (NCT04408794) of zavegepant for the acute treatment of migraine. Adults aged ≥18 years with a history of 2 to 8 moderate-severe monthly migraine attacks were eligible. Subjects self-administered 1 dose of zavegepant 10 mg nasal spray per day as needed to treat migraine attacks of any severity, up to 8 times per month, for 52 weeks. Months were defined as 4-week intervals. Subjects who took ≥1 dose of zavegepant were included in the analysis.

Results:

Of the 608 subjects entering the long-term treatment phase, 603 were treated with zavegepant 10 mg nasal spray. At baseline, the mean (SD) number of moderate-severe attacks per month was 5.0 (1.89), and 18.1% of treated subjects were using preventive migraine medication. Treatment-emergent adverse events (AEs) reported in ≥5% of subjects were dysgeusia (39.1%); nasal discomfort (10.3%); COVID-19 (7.5%); nausea (6.1%); nasal congestion and throat irritation (5.5% each); and back pain (5.3%). In total, 6.8% of treated subjects discontinued due to AEs; 1.5% discontinued due to dysgeusia. The majority of AEs (96.4%) were mild to moderate in intensity. Of the 7 serious AEs reported, none was considered related to treatment by the investigators. Aminotransferases >3x the upper limit of normal (ULN) occurred in 2.6% of subjects, none of whom had concurrent elevations in bilirubin >2x ULN. Subjects took a mean (SD) of 3.1 (1.6) zavegepant doses per month.

Conclusions:

This 1-year open-label safety study demonstrated favorable safety and tolerability for zavegepant 10 mg nasal spray for the acute treatment of migraine.