Evaluate the effects of concomitant use of CGRP monoclonal antibodies (mAbs) on the safety and tolerability of zavegepant nasal spray in the acute treatment of migraine.

Patients receiving preventive treatment for migraine usually also require acute prescription migraine treatment. Zavegepant nasal spray is a small molecule CGRP receptor antagonist for the acute treatment of migraine. Given mechanistic overlap of zavegepant and CGRP targeted mAbs, characterizing safety of concomitant administration merits exploration.

This subgroup analysis is based on a Phase 2/3, 1-year open-label safety study (NCT04408794) of zavegepant 10 mg nasal spray for the acute treatment of migraine. Adults aged ≥18 years with a history of 2 to 8 moderate-severe monthly migraine attacks were eligible. A stable dose of a CGRP mAb for preventive treatment of migraine was permitted during open-label zavegepant treatment.

Of the 603 subjects treated with zavegepant 10 mg nasal spray, 39 (6.5%) reported current or concomitant use of a CGRP mAb (erenumab 22, galcanezumab 11, fremanezumab 7); 564 (93.5%) did not use a CGRP mAb. The incidence of AEs on treatment was comparable in subjects using and not using a CGRP mAb (76.9% vs 76.2%). The most common AEs occurring in subjects using a CGRP mAb were dysgeusia [28.2% (11/39)], nasal discomfort [15.4% (6/39)], back pain [15.4% (6/39)], throat irritation [12.8% (5/39)], and arthralgia [12.8% (5/39)]. No serious AEs were reported in any subjects using a CGRP mAb. The rate of discontinuation due to AEs was similar in those using and not using a CGRP mAb (7.7% vs 6.7%). No new safety concerns were identified.

Up to 1 year of open-label treatment with zavegepant 10 mg nasal spray was safe and tolerable for the acute treatment of migraine whether or not subjects were concomitantly using CGRP mAbs for preventive treatment.