Intranasal zavegepant offers freedom from pain in women with acute migraine

The use of nasal spray zavegepant 10 mg provides freedom from pain and the most bothersome migraine symptom (MBS*) at 2 hours after treatment in women with acute migraine, according to the pooled analysis of the two trials presented at AAN 2024.

“The prevalence of migraine is approximately 2–3 times higher in women than in men,” said the researchers. However, the efficacy and safety of zavegepant for the acute treatment of migraine have not been evaluated in a population comprised exclusively of women.”

Using data from the two double-blind, placebo-controlled studies, 1,723 women with acute migraine, primarily migraine type without aura, were randomized to receive zavegepant 10 mg nasal spray (n=839; mean age 41.2 years) or placebo (n=884; mean age 40.3 years) for the treatment of a single migraine attack of moderate or severe intensity.

In this subgroup analysis of women with acute migraine, significantly more patients treated with zavegepant 10 mg achieved freedom from pain (23.2 percent vs 14.6 percent; p<0.0001) and MBS (41.7 percent vs 32.4 percent; p<0.0001) at 2 hours after receiving the dose. [AAN 2024, abstract 004]

Moreover, patients in the zavegepant group were more likely to experience rapid pain relief as early as 15 minutes after intranasal administration (17.4 percent vs 7.9 percent; p<0.0001) than those in the placebo group, with more zavegepant recipients returning to normal function within 30 minutes after receiving the dose (9.1 percent vs 5.8 percent; p_nominal=0.0119).

“The current pooled subgroup data are generally consistent with the findings for the overall populations of the two studies,” said the researchers. [Headache 2022;62:1153-1163; Lancet Neurol 2023;22:209-217]

Safety endpoints

Adverse events (AEs) occurred in 28.9 percent of patients in the zavegepant group and 15.3 percent in the placebo group, with only one patient in each group reporting serious AEs. No AEs led to study drug discontinuation. “Zavegepant was well tolerated in this subgroup of women,” noted the researchers.

In another study, a long-term treatment study of zavegepant showed a favourable safety and tolerability profile in female participants, which was generally consistent with that of male participants. [AAN 2024, abstract 001]

The rates of serious AEs were also similar in both females and males (1.2 percent for both cohorts), with no serious AEs related to zavegepant. However, the researchers said caution is warranted in interpreting the result, mainly due to the relatively small number of male participants.

“Overall, the pooled analysis showed that zavegepant 10 mg was effective and well tolerated compared with placebo for the acute treatment of migraine in women,” they concluded.