Skip to main content
Top
Published in: Drugs 3/2020

Open Access 01-02-2020 | Migraine | AdisInsight Report

Ubrogepant: First Approval

Author: Lesley J. Scott

Published in: Drugs | Issue 3/2020

Login to get access

Abstract

Ubrogepant (Ubrelvy™) is an orally administered, small molecule, highly-selective, calcitonin gene-related peptide (CGRP) antagonist that was developed by Allergan under license to Merck & Co. as an acute treatment for migraine. In December 2019, ubrogepant received its first global approval in the USA for the acute treatment of migraine (± aura) in adults. This article summarizes the milestones in the development of ubrogepant leading to its first global approval for the acute treatment of migraine (± aura) in adults.
Literature
1.
go back to reference Holland PR, Goadsby PJ. Targeted CGRP small molecule antagonists for acute migraine therapy. Neurotherapeutics. 2018;15(2):304–12.CrossRef Holland PR, Goadsby PJ. Targeted CGRP small molecule antagonists for acute migraine therapy. Neurotherapeutics. 2018;15(2):304–12.CrossRef
2.
go back to reference Chan C, Goadsby PJ. Recent advances in pharmacotherapy for episodic migraine. CNS Drugs. 2019;33(11):1053–71.CrossRef Chan C, Goadsby PJ. Recent advances in pharmacotherapy for episodic migraine. CNS Drugs. 2019;33(11):1053–71.CrossRef
3.
go back to reference Edvinsson L, Haanes KA, Warfvinge K, et al. CGRP as the target of new migraine therapies—successful translation from bench to clinic. Nat Rev Neurol. 2018;14(6):338–50.CrossRef Edvinsson L, Haanes KA, Warfvinge K, et al. CGRP as the target of new migraine therapies—successful translation from bench to clinic. Nat Rev Neurol. 2018;14(6):338–50.CrossRef
4.
go back to reference Allergan, Merck. Allergan enters into licensing agreement with Merck to obtain exclusive worldwide rights to CGRP migraine development program [media release]. 7 Jul 2015. Allergan, Merck. Allergan enters into licensing agreement with Merck to obtain exclusive worldwide rights to CGRP migraine development program [media release]. 7 Jul 2015.
7.
go back to reference Moore E, Burgey CS, Fraley M, et al. Characterization of ubrogepant: a potent and selective antagonist of the human calcitonin gene-related peptide receptor [abstract]. Headache. 2019;59(Suppl 1):89–90. Moore E, Burgey CS, Fraley M, et al. Characterization of ubrogepant: a potent and selective antagonist of the human calcitonin gene-related peptide receptor [abstract]. Headache. 2019;59(Suppl 1):89–90.
8.
go back to reference Edvinsson L, Rubio-Beltran E, Chan K, et al. Characterization of the effects of the calcitonin gene-related peptide (CGRP) receptor antagonists, atogepant and ubrogepant, on isolated human coronary, cerebral, and middle meningeal arteries [abstract no. OR13]. Headache. 2019;59(Suppl 1):13. Edvinsson L, Rubio-Beltran E, Chan K, et al. Characterization of the effects of the calcitonin gene-related peptide (CGRP) receptor antagonists, atogepant and ubrogepant, on isolated human coronary, cerebral, and middle meningeal arteries [abstract no. OR13]. Headache. 2019;59(Suppl 1):13.
10.
go back to reference Li C, Palcza J, Xu J, et al. Absence of clinically significant drug interactions with coadministration of ubrogepant and an ethinyl estradiol/norgestimate oral contraceptive in healthy female subjects: a phase 1 pharmacokinetic analysis [abstract no. P100]. Headache. 2019;59(Suppl 1):91. Li C, Palcza J, Xu J, et al. Absence of clinically significant drug interactions with coadministration of ubrogepant and an ethinyl estradiol/norgestimate oral contraceptive in healthy female subjects: a phase 1 pharmacokinetic analysis [abstract no. P100]. Headache. 2019;59(Suppl 1):91.
11.
go back to reference Jakate A, Boinpally R, Butler M, et al. Single therapeutic doses of ubrogepant are not associated with a clinically relevant drug-drug interaction when co-administered with acetaminophen or naproxen [abstract no. P96]. Headache. 2019;59(Suppl 1):87–8. Jakate A, Boinpally R, Butler M, et al. Single therapeutic doses of ubrogepant are not associated with a clinically relevant drug-drug interaction when co-administered with acetaminophen or naproxen [abstract no. P96]. Headache. 2019;59(Suppl 1):87–8.
12.
go back to reference Jakate A, Boinpally R, Butler M, et al. Coadministration of single therapeutic oral doses of ubrogepant and sumatriptan produces no clinically relevant pharmacokinetic interactions [abstract no. P95]. Headache. 2019;59(Suppl 1):86–7. Jakate A, Boinpally R, Butler M, et al. Coadministration of single therapeutic oral doses of ubrogepant and sumatriptan produces no clinically relevant pharmacokinetic interactions [abstract no. P95]. Headache. 2019;59(Suppl 1):86–7.
13.
go back to reference Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230–41.CrossRef Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230–41.CrossRef
14.
go back to reference Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA. 2019;322(19):1887–98.CrossRef Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA. 2019;322(19):1887–98.CrossRef
15.
go back to reference Dodick DW, Goadsby PJ, Lakkis H, et al. Ubrogepant achieves onset of pain relief at 1 hour for the acute treatment of migraine [abstract no. P103]. Headache. 2019;59(Suppl 1):92–3. Dodick DW, Goadsby PJ, Lakkis H, et al. Ubrogepant achieves onset of pain relief at 1 hour for the acute treatment of migraine [abstract no. P103]. Headache. 2019;59(Suppl 1):92–3.
16.
go back to reference Blumenfeld AM, Goadsby PJ, Dodick DW, et al. Ubrogepant is effective for the acute treatment of migraine in patients for whom triptans are ineffective [abstract no. IOR02]. Headache. 2019;59(Suppl 1):19. Blumenfeld AM, Goadsby PJ, Dodick DW, et al. Ubrogepant is effective for the acute treatment of migraine in patients for whom triptans are ineffective [abstract no. IOR02]. Headache. 2019;59(Suppl 1):19.
17.
go back to reference Ailani J, Blumenfeld AM, Klein B, et al. An optional second dose of ubrogepant is effective in achieving 2-hour pain freedom in the acute treatment of migraine [abstract no. P112]. Headache. 2019;59(Suppl 1):98. Ailani J, Blumenfeld AM, Klein B, et al. An optional second dose of ubrogepant is effective in achieving 2-hour pain freedom in the acute treatment of migraine [abstract no. P112]. Headache. 2019;59(Suppl 1):98.
18.
go back to reference Voss T, Lipton RB, Dodick DW, et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016;36(9):887–98.CrossRef Voss T, Lipton RB, Dodick DW, et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016;36(9):887–98.CrossRef
20.
go back to reference Lipton RB, Ailani J, Hutchinson S, et al. Efficacy is maintained with long-term intermittent use of ubrogepant for the acute treatment of migraine [abstract no. P135]. Headache. 2019;59(Suppl 1):110. Lipton RB, Ailani J, Hutchinson S, et al. Efficacy is maintained with long-term intermittent use of ubrogepant for the acute treatment of migraine [abstract no. P135]. Headache. 2019;59(Suppl 1):110.
21.
go back to reference Ankrom W, Bondiskey P, Li CC, et al. Ubrogepant is not associated with clinically meaningful elevations of alanine aminotransferase in healthy adult males. Clin Transl Sci. 2020:1–11. Ankrom W, Bondiskey P, Li CC, et al. Ubrogepant is not associated with clinically meaningful elevations of alanine aminotransferase in healthy adult males. Clin Transl Sci. 2020:1–11.
22.
go back to reference Goadsby PJ, Tepper SJ, Watkins PB, et al. Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: randomized, placebo-controlled trial in healthy adults. Cephalalgia. 2019;39(14):1753–61.CrossRef Goadsby PJ, Tepper SJ, Watkins PB, et al. Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: randomized, placebo-controlled trial in healthy adults. Cephalalgia. 2019;39(14):1753–61.CrossRef
23.
go back to reference Hutchinson S, Dodick DW, Treppendahl C, et al. Ubrogepant for the acute treatment of migraine: pooled safety and tolerability from ACHIEVE I and ACHIEVE II phase 3 studies [abstract no. P154]. Headache. 2019;59(Suppl 1):120. Hutchinson S, Dodick DW, Treppendahl C, et al. Ubrogepant for the acute treatment of migraine: pooled safety and tolerability from ACHIEVE I and ACHIEVE II phase 3 studies [abstract no. P154]. Headache. 2019;59(Suppl 1):120.
24.
go back to reference Hutchinson S, Silberstein SD, Blumenfeld AM, et al. Safety of ubrogepant in participants with moderate to high cardiovascular risk [abstract no. P124]. Headache. 2019;59(Suppl 1):104–5. Hutchinson S, Silberstein SD, Blumenfeld AM, et al. Safety of ubrogepant in participants with moderate to high cardiovascular risk [abstract no. P124]. Headache. 2019;59(Suppl 1):104–5.
25.
go back to reference Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine; phase 3, randomized, 52-week extension trial. Headache. 2020;60:141–52.CrossRef Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine; phase 3, randomized, 52-week extension trial. Headache. 2020;60:141–52.CrossRef
Metadata
Title
Ubrogepant: First Approval
Author
Lesley J. Scott
Publication date
01-02-2020
Publisher
Springer International Publishing
Keywords
Migraine
Aura
Published in
Drugs / Issue 3/2020
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-020-01264-5

Other articles of this Issue 3/2020

Drugs 3/2020 Go to the issue

AdisInsight Report

Givosiran: First Approval

AdisInsight Report

Golodirsen: First Approval