Migraine exhibits a 2-3 fold higher prevalence in women compared to men.¹ Among females, migraines are typically of longer duration, more debilitating, and more likely to recur post-initial treatment.¹ Studies have found that triptans were ineffective in up to 40% of migraine attacks.¹  Rimegepant, an orally administered small-molecule calcitonin gene-related peptide receptor antagonist, is indicated for both migraine prevention and acute treatment.¹ This novel medication has established its safety and efficacy in four preceding randomized trials.¹

In this post-hoc subgroup analysis, the efficacy of 75mg rimegepant was compared with placebo specifically in the adult female population.¹ Data was pooled from female patients suffering from migraine in both the preventative and acute treatment setting across 4 randomized studies.¹ In both the acute treatment and prevention studies, participants were adults with ≥1 year of migraine who were randomized to receive either rimegepant or placebo and had matched baseline characteristics in both acute and preventative studies.¹ They had a similar distribution in terms of race, weight, body mass index (BMI), as well as age.¹ The disease history in either group was also matched in terms of the number and duration of attacks, migraine types, and the most bothersome symptoms which included photophobia, phonophobia, and nausea.¹ The use of preventative migraine medication was also similar in both the rimegepant arm and placebo arm.¹

The acute setting included 3 double-blinded randomized, placebo-controlled, multicenter trials in which participants had 2-8 moderate to severe migraine attacks per month.¹ They also had <15 days of migraine or headaches within the last 3 months.¹ Of the 3,553 participants across the 3 trials, 86% were female (n=3,063).¹ They were randomized 1:1 to receive rimegepant (n=1,529) and placebo (n=1,534).¹ Preventative medication was allowed if the dose had been stable for ≥3 months.¹ The co-primary endpoints were freedom from pain and the most bothersome symptom (MBS) at 2 hours post-dose.¹ Rimegepant has demonstrated superior efficacy in both co-primary endpoints in the acute prevention population.¹ 21.1% of participants on rimegepant achieved pain freedom vs. only 12.2% with placebo (p<0.0001), while 35.9% of participants on rimegepant achieved pain freedom vs. 26.7% in the placebo arm (p<0.0001).¹

In the prevention setting, the data from the 12-week, randomized, double-blind, placebo-controlled trial was used, in which participants had 4-18 moderate to severe migraine attacks as well as ≥6 migraine days and ≤18 headache days during the observation period.¹ Of the 695 participants, 83% were female (n=577).¹ They were randomized 1:1 to receive rimegepant (n=282) and placebo (n=295).¹ The primary endpoint was the change in the mean number of migraine days per month in weeks 9-12 compared with the observation period.¹ Rimegepant has also achieved a significantly better outcome in the preventative management study, the number of mean migraine days per month is reduced by 4.5 days (95% CI: 4.25-4.75) vs. 3.7 days (95% CI: 3.45-3.95) with placebo, with a least-square mean difference of -0.8 days (95% CI: -1.47 to -0.08; p=0.0285).¹

In summary, this post-hoc analysis showed that rimegepant is effective in both acute treatment and prevention of migraine among adult women.¹