Ubrogepant Most Effective in Mild vs Moderate or Severe Headache Pain Intensity

Presenting at AHS 2022, researchers assessed the efficacy of a 1-year treatment period with ubrogepant 50 or 100 mg in patients with migraine attacks with mild and moderate or severe pain.

The use of ubrogepant is more effective for the treatment of migraine headache when the pain intensity is mild compared with when the pain intensity is moderate or severe, according to study findings presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, held from June 9-12, in Denver, Colorado, and virtually.

The researchers noted ubrogepant, a small-molecule calcitonin gene-related peptide receptor antagonist, has demonstrated efficacy in the treatment of migraine with mild pain intensity versus moderate or severe in a previous pooled analysis. They conducted a posthoc, within-participant analysis to evaluate the efficacy of ubrogepant 50 mg or 100 mg in participants who were treating mild and moderate or severe pain associated with migraine attacks during a 52-week treatment period.

Data from the original pooled analysis, a phase 3, open-label, long-term safety extension trial (ClinicalTrials.gov Identifier: NCT02873221) was used. The data included patients who received treatment with ubrogepant with valid efficacy data who treated both 3 or more mild and 3 or more moderate or severe pain migraine attacks.

Efficacy measures in the current analysis included pain freedom at 2 hours after the initial dose (2hPF) and the absence of migraine-associated symptoms.

A total of 117 patients in the analysis population were treated with ubrogepant 50 mg and 127 individuals were treated with ubrogepant 100 mg. Overall, of the patients in the ubrogepant 100-mg treatment group, 51.2% with mild pain and 28.9% of those with moderate or severe pain experienced 2hPF (odds ratio [OR], 2.58; 95% CI, 2.24-2.96; P <.001). In these participants, the absence of photophobia was 65.2% vs 47.5%, respectively (OR, 2.07; 95% CI, 1.80-2.37; P <.001), the absence of phonophobia was 76.6% vs 63.1%, respectively (OR, 1.91; 95% CI, 1.66- 2.20; P <.001), and the absence of nausea was 88.0% vs 79.1%, respectively (OR, 1.94; 95% CI, 1.63- 2.31; P <.001). Similar results were reported in participants in the ubrogepant 50-mg treatment group.

The researchers concluded that the current study findings “confirm previous population-level data in ubrogepant-treated participants and suggest that ubrogepant is more effective when treating migraine headache while pain intensity is mild [vs] moderate/severe.” These results underscore the need to instruct patients to treat as soon as their headache begins.


Lipton RB, Dodick DW, Goadsby PJ, et al. Within-person analysis of ubrogepant treatment of mild versus moderate-severe headache pain during a phase 3 long-term safety extension trial. Presented at: AHS 2022 Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado. Poster 148.