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

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.

READ MORE: Rimegepant, Ubrogepant, Lasmiditan All Safe and Effective for Acute Migraine Treatment

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.

For more coverage of AHS 2021, click here.

1. Pavlovic JM, Ailani J, Hutchinson S, et al. Ubrogepant was safe and well tolerated in the acute treatment of perimenstrual migraine. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P129
2. FDA approves new treatment for adults with migraine. FDA. December 23, 2019. Accessed June 7, 2021. fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine. Accessed December 23, 2019.
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