Phase 3 Studies: Ubrogepant Decreases Headaches, Improves Patient Outcomes for Migraine

By Cassie Homer
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Treatment with ubrogepant, a novel oral CGRP receptor antagonist, increased normal patient function and satisfaction and reduced incidence of migraine compared with placebo among patients with acute migraine, according to data presented at the American Academy of Neurology 2019 Annual Meeting in Philadelphia.

The presentation included data from two phase 3 trials: ACHIEVE I (n = 1,327) and ACHIEVE II (n = 1,355). Migraine patients in ACHIEVE I were randomly assigned to treatment with placebo, ubrogepant 50 mg or ubrogepant 100 mg, and in ACHIEVE II to placebo, ubrogepant 25 mg or ubrogepant 50 mg.


Pill bottle. Source: Getty

Overall, compared with placebo, patients treated with ubrogepant at any dose, across both trials, reported significantly greater satisfaction, improved symptoms and higher rates of freedom from pain.

Two hours after treatment, more patients treated with ubrogepant reported normal function (ACHIEVE I 50mg: 41%; 100mg: 43%; ACHIEVE II 25mg: 43%; 50mg: 41%; all at least P = 0.0118). More ubrogepant-treated patients reported being satisfied/extremely satisfied with study medication (ACHIEVE I 50mg: 36%; 100mg: 36%; ACHIEVE II 25mg: 35%; 50mg: 38%; all at least P = 0.00118); and indicated their migraine was much/very much better (ACHIEVE I 50mg: 34%; 100mg: 34%; ACHIEVE II 25mg: 34%; 50mg: 33%, all at least P = .0009 ) compared with placebo.

Patients treated with ubrogepant vs. placebo had higher pain freedom and pain relief.

“In both trials a higher proportion of ubrogepant- than placebo-treated patients reported normal function and overall satisfaction with treatment and indicated their migraine was much better,” Richard B. Lipton of the Albert Einstein College of Medicine, and colleagues wrote in the abstract. “The results of these patient-centered outcomes were found to be clinically meaningful and reinforce the potential benefits of ubrogepant in the acute treatment of migraine.”