To compare the efficacy and safety of zavegepant 10 mg with placebo in the acute treatment of migraine in women.

Migraine is more commonly reported in women than in men. Zavegepant is a small molecule calcitonin gene-related peptide receptor antagonist administered as a nasal spray for the acute treatment of migraine.

These pooled subgroup analyses were based on data from 2 double-blind, randomized, placebo-controlled studies (NCT03872453, NCT04571060). Participants with a history of 2–8 migraine attacks of moderate or severe pain intensity per month treated a single migraine attack of moderate or severe pain intensity with zavegepant 10 mg or placebo. Co-primary efficacy endpoints at 2 hours postdose were freedom from pain and freedom from the most bothersome symptom (MBS). Secondary/exploratory efficacy endpoints included pain relief at 15 minutes postdose and return to normal function at 30 minutes postdose. Treatment groups were compared in the subgroup of women and the overall population using Mantel-Haenszel risk estimation, with nominal P-values.

Of 2061 efficacy-evaluable participants, 83.6% were female (N=1723: zavegepant, n=839; placebo, n=884). In the subgroup of women at 2 hours postdose, response rates for zavegepant vs placebo were 23.2% vs 14.6% (P<0.0001) for freedom from pain, and 41.7% vs 32.4% (P<0.0001) for freedom from the MBS. Response rates for pain relief at 15 minutes postdose were 17.4% vs 7.9% (P<0.0001). Response rates for return to normal function at 30 minutes postdose were 9.1% vs 5.8% (P=0.0119). Zavegepant was well tolerated.

In these pooled subgroup analyses, zavegepant 10 mg was effective and well tolerated compared with placebo for the acute treatment of migraine in women. Funded by Pfizer.