UBRELVY® (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY is not indicated for the preventive treatment of migraine.
Drug Interactions: UBRELVY is contraindicated with concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).
Hypersensitivity Reactions: UBRELVY is contraindicated in patients with a history of serious hypersensitivity to ubrogepant or any ingredient of the product. Cases, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported. Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions were not serious, and some led to discontinuation. If a serious or severe reaction occurs, discontinue UBRELVY and institute appropriate therapy.
The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).
Please see full Prescribing Information available at this booth.
© 2024 AbbVie. All rights reserved.
All trademarks are the property of their respective owners.
US-UBR-240278 10/24
References: 1. Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023;402(10419):2307-2316. 2. UBRELVY. Package insert. AbbVie Inc; 2023. 3. Data on file. AbbVie Inc.
References: 1. Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023;402(10419):2307-2316. 2. Data on file. AbbVie Inc.
References: 1. The timeline of a migraine attack. American Migraine Foundation. January 18, 2018. Accessed October 10, 2024. https://americanmigrainefoundation.org/resource-library/timeline-migraine-attack/ 2. Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023;402(10419):2307-2316. 3. Lipton RB, Reed ML, Fanning KM, Contreras-De Lama J, Adams AM, Buse DC. Characterizing the pre- and post-headache phases of migraine: interim results from the CaMEO-International Study (US sample). Poster presented at: 64th Annual Scientific Meeting of the American Headache Society; June 9-12, 2022; Denver, CO.
Co-primary endpoint: Pain freedom at 2 hours with a single dose1,2*
21% of patients experienced pain freedom with UBRELVY 100 mg (95/448) and UBRELVY 50 mg (182/886) vs 13% placebo (119/912).1,3,4*
Data above is in reference to ACHIEVE pivotal trials.
*Pain freedom was defined as a reduction from moderate or severe headache pain to no pain.1
ACHIEVE PIVOTAL TRIALS DESIGN1,4-6
Two randomized, double-blind, placebo-controlled, multicenter trials evaluated the efficacy and safety of UBRELVY in adults who had 2 to 8 migraine attacks of moderate to severe pain per month. Data were pooled for the 50 mg analysis. A co-primary endpoint at 2 hours for UBRELVY vs placebo was freedom from most bothersome symptom (photophobia, phonophobia, nausea): 50 mg: 39% (342/883) vs 28% (251/910) or 100 mg: 38% (169/448) vs 28% (126/454).
References: 1. UBRELVY. Package insert. AbbVie Inc; 2023. 2. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant, an acute treatment for migraine, improved patient-reported functional disability and satisfaction in 2 single-attack phase 3 randomized trials, ACHIEVE I and II. Headache. 2020;60(4):686-700. 3. Data on file. AbbVie Inc. 4. Hutchinson S, Dodick DW, Treppendahl C, et al. Ubrogepant for the acute treatment of migraine: pooled efficacy, safety, and tolerability from the ACHIEVE I and ACHIEVE II phase 3 randomized trials. Neurol Ther. 2021;10(1):235-249. 5. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 6. 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):1887-1898.