Ubrogepant Demonstrates Safety, Efficacy in Treating Perimenstrual Migraine
Absence of photophobia, phonophobia, and nausea were achieved in a similar percentage of perimenstrual and non-perimenstrual ubrogepant-treated attacks.
Jelena M. Pavlovic, MD, PhD
Data from a post-hoc analysis of the phase 3 ACHIEVE 1 & 2 studies (NCT02873221; NCT02867709) showed that treatment with ubrogepant (Ubrelvy; Allergan) was safe, well tolerated, and did not significantly differ when treating perimenstrual migraine (pmM) attacks compared to non-pmM attacks.1
Lead author Jelena M. Pavlovic, MD, PhD, associate professor, Albert Einstein College of Medicine, Montefiore Medical Center, and colleagues concluded, “the findings could have meaningful implications by supporting a simplified regimen with a single acute treatment for multiple types of migraine attacks.”
Presented at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6, the 52-week study rerandomized those who completed 1 of 2 lead-in ACHIEVE trials 1:1:1 to usual care (n = 417), ubrogepant 50 mg (n = 417), or ubrogepant 100 mg (n = 420). Among all female participants, 1329 pmM attacks and 16,145 non-pmM attacks were treated with ubrogepant.
At 2 hours post dose, 28.7% and 29.7% of patients in the in 50- and 100-mg dose groups experienced pain freedom from pmM, while pain freedom of non-pmM occurred in 22.1% and 25.3% of those treated, respectively. Pain relief of pmM and non-pmM was experienced by 64.8% and 65.2% of patients in the ubrogepant 50-mg group, and increased to 67.1% and 68.4% of patients, respectively, in the 100-mg group.
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Absence of photophobia, phonophobia, and nausea at 2 hours were achieved in a similar percentage of pmM and non-pmM ubrogepant-treated attacks. Treatment with ubrogepant led to achieved absence of photophobia in at least 37% of those in both groups, while at least 44% achieved absence of phonophobia, and at least 65.7% achieved absence of nausea in both groups.
At 2 hours post-dose, 41.7% and 35.8% of pmM and non-pmM attacks treated with ubrogepant 50-mg were associated with a return to normal function (odds ratio [OR], 1.1 [95% CI, 1.0-1.4]; P = .160). Those in the 100-mg group experienced similar results, with 38.5% and 39.3% of pmM and non-pmM ubrogepant-treated attacks associated with a return to normal function at 2 hours, respectively (OR, 1.0 [95% CI, 0.8-1.2]; P = .962).
Use of rescue medication or use of an optional second dose at 2 hours did not differ significantly between groups. In total, 12.4% and 6.6% of those in the 50- and 100-mg groups, respectively, used rescue medication to treat pmM. In comparison, 14.2% and 10.7% of those in the same groups, respectively, needed rescue medication for non-pmM. An optional second dose was needed in 40.3% and 36.1% of patients in the 50-mg group to treat pmM and non-pmM, respectively, while 34.9% and 33.2% of patients in the 100-mg group needed second dose as well.
Pavlovic and colleagues also examined a subgroup of 248 women who reported at least 1 pmM attack. Within this group, treatment-related adverse events (AEs) were reported by 8.8% of those in the ubrogepant 50-mg group and 12.8% of those in the 100-mg subgroup. No deaths were reported in the study, and discontinuation from the study due to AEs occurred in 2 patients in both dose groups.
In December 2019, the FDA approved ubrogepant for the acute treatment of migraine with or without aura in adults, making it the first-in-class oral calcitonin gene-related peptide (CGRP) antagonist for this indication.2 The new drug application was supported by data from both ACHIEVE 1 and 2, as well as 2 additional safety studies – UBR-MD-04 and 3110-105-002.
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