TY - JOUR
T1 - Ubrogepant for the Acute Treatment of Migraine
T2 - Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials
AU - Hutchinson, Susan
AU - Dodick, David W.
AU - Treppendahl, Christina
AU - Bennett, Nathan L.
AU - Yu, Sung Yun
AU - Guo, Hua
AU - Trugman, Joel M.
N1 - Funding Information:
Writing and editorial assistance was provided to the authors by Lela Creutz, PhD, and Cory R. Hussar, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie.
Funding Information:
We thank the study participants and all those involved in analyzing the data. This study and the Rapid Service Fee for submission were sponsored by Allergan (prior to its acquisition by AbbVie). Writing and editorial assistance was provided to the authors by Lela Creutz, PhD, and Cory R. Hussar, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. This manuscript is based in part on work that has been previously presented at the American Headache Society 61st Annual Scientific Meeting, July 11–14, 2019; 19th Congress of the International Headache Society, September 5–8, 2019; 13th Annual Headache Cooperative of the Pacific, January 24–25, 2020; the Diamond Headache Clinic Research & Educational Foundation’s 2020 Meeting, February 14–17, 2020; the American Headache Society Virtual Annual Scientific Meeting, June 2020; 72nd Annual Meeting of the American Academy of Neurology, April 25–May 1, 2020 (virtual); the American Headache Society Virtual Annual Scientific Meeting, June 13, 2020; AANPconnect: An Online Conference Experience, September 10–December 31, 2020; and the American Academy of Family Physicians FMX Family Medicine Experience, October 13–17, 2020 (virtual). Susan Hutchinson has served on advisory boards for AbbVie, Alder, Amgen, Avanir, Biohaven, electroCore, Eli Lilly, Supernus, Theranica, Teva, and Upsher-Smith.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/6
Y1 - 2021/6
N2 - Introduction: Ubrogepant is an oral, small-molecule calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine. The efficacy and safety of ubrogepant were demonstrated in two pivotal phase 3, single-attack, randomized, placebo-controlled trials (ACHIEVE I and ACHIEVE II). Methods: We conducted a post hoc analysis of pooled data from the ACHIEVE trials to evaluate the efficacy, safety, and tolerability of ubrogepant 50 mg (the only dose evaluated in both trials) versus placebo across a large population of participants with migraine. The coprimary efficacy outcomes were pain freedom and absence of the most bothersome migraine-associated symptom (including photophobia, phonophobia, and nausea) at 2 h post dose. Secondary outcomes included pain relief at 2 h post dose, sustained pain relief and pain freedom from 2 to 24 h, and absence of specific migraine-associated symptoms at 2 h post dose. Results: A total of 2240 eligible participants were randomized to placebo (n = 1122) or ubrogepant 50 mg (n = 1118) in the ACHIEVE trials. Pain freedom at 2 h was reported in 13.0% of participants in the pooled placebo group and 20.5% in the pooled ubrogepant 50 mg group (odds ratio [OR] 1.72; 95% confidence interval [CI] 1.34, 2.22; P < 0.001). Absence of the most bothersome migraine-associated symptom at 2 h was reported by 27.6% in the pooled placebo group and by 38.7% in the pooled ubrogepant 50 mg group (OR 1.68; 95% CI 1.37, 2.05; P < 0.001). Adverse events (AEs) within 48 h after the initial or optional second dose were reported by 11.5 and 11.2% of participants in the pooled placebo and pooled ubrogepant 50 mg groups, respectively. The most common AE was nausea (1.8 and 1.9%, respectively). No serious AEs related to treatment or discontinuations due to AEs were reported. Conclusion: These results further support the efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine. Trial Registration: ClinicalTrials.gov
AB - Introduction: Ubrogepant is an oral, small-molecule calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine. The efficacy and safety of ubrogepant were demonstrated in two pivotal phase 3, single-attack, randomized, placebo-controlled trials (ACHIEVE I and ACHIEVE II). Methods: We conducted a post hoc analysis of pooled data from the ACHIEVE trials to evaluate the efficacy, safety, and tolerability of ubrogepant 50 mg (the only dose evaluated in both trials) versus placebo across a large population of participants with migraine. The coprimary efficacy outcomes were pain freedom and absence of the most bothersome migraine-associated symptom (including photophobia, phonophobia, and nausea) at 2 h post dose. Secondary outcomes included pain relief at 2 h post dose, sustained pain relief and pain freedom from 2 to 24 h, and absence of specific migraine-associated symptoms at 2 h post dose. Results: A total of 2240 eligible participants were randomized to placebo (n = 1122) or ubrogepant 50 mg (n = 1118) in the ACHIEVE trials. Pain freedom at 2 h was reported in 13.0% of participants in the pooled placebo group and 20.5% in the pooled ubrogepant 50 mg group (odds ratio [OR] 1.72; 95% confidence interval [CI] 1.34, 2.22; P < 0.001). Absence of the most bothersome migraine-associated symptom at 2 h was reported by 27.6% in the pooled placebo group and by 38.7% in the pooled ubrogepant 50 mg group (OR 1.68; 95% CI 1.37, 2.05; P < 0.001). Adverse events (AEs) within 48 h after the initial or optional second dose were reported by 11.5 and 11.2% of participants in the pooled placebo and pooled ubrogepant 50 mg groups, respectively. The most common AE was nausea (1.8 and 1.9%, respectively). No serious AEs related to treatment or discontinuations due to AEs were reported. Conclusion: These results further support the efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine. Trial Registration: ClinicalTrials.gov
KW - Calcitonin gene–related peptide
KW - Gepant
KW - Headache
KW - Migraine
KW - Ubrogepant
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U2 - 10.1007/s40120-021-00234-7
DO - 10.1007/s40120-021-00234-7
M3 - Article
AN - SCOPUS:85101203709
SN - 2193-8253
VL - 10
SP - 235
EP - 249
JO - Neurology and Therapy
JF - Neurology and Therapy
IS - 1
ER -