Safety and efficacy of ubrogepant for the acute treatment of perimenstrual migraine attacks: A post hoc analysis

Abstract Objective To evaluate the efficacy and safety of ubrogepant for the acute treatment of perimenstrual migraine (pmM) attacks. Background Ubrogepant is an oral calcitonin gene‐related peptide receptor antagonist approved for the acute treatment of migraine in adults. Methods After completing one of two phase 3 trials, participants could enroll in a phase 3, 52‐week, open‐label, long‐term safety extension trial and were re‐randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg. This post hoc analysis evaluated the efficacy of ubrogepant in a subset of women who treated ≥1 pmM or non‐pmM attack with ubrogepant. A pmM attack started on or between 2 days before and the first 3 days of menstrual bleeding. Mean (standard deviation [SD]) percentages of ubrogepant‐treated attacks achieving 2‐h pain freedom and pain relief were reported, with outcomes weighted equally by participant. Results Of 734 women in the modified intent‐to‐treat population, 354 reported ≥1 menstrual cycle start date and a ubrogepant‐treated headache day in the same month. A qualifying pmM and non‐pmM attack was reported by 278 and 716 women, respectively. Pain freedom at 2 h was achieved in a mean (SD) of 28.7% (37.4) of pmM attacks and 22.1% (26.9) of non‐pmM attacks treated with ubrogepant 50 mg ( p = 0.054) and 29.7% (35.2) versus 25.3% (26.3) of attacks treated with ubrogepant 100 mg ( p = 0.757). No difference was found in the mean percentage of ubrogepant‐treated pmM and non‐pmM attacks that achieved 2‐h pain relief with ubrogepant 50 mg (64.8% [39.9] vs. 65.2% [32.4]; p = 0.683) and with 100 mg (67.1% [37.4] vs. 68.4% [30.2]; p = 0.273). Treatment‐related treatment‐emergent adverse events were reported by 8.8% (12/137) and 12.8% (18/141) in the ubrogepant 50 and 100 mg pmM subgroups, respectively. Conclusions Ubrogepant demonstrated similar efficacy for the treatment of pmM and non‐pmM attacks. No new safety signals were identified.