When it comes to migraine treatment,
Choose UBRELVY® FOR THE POWER OF ZERO MIGRAINE PAIN1,2
Explore how UBRELVY can help patients manage migraine pain.
PRE-HEADACHE
Clinical evidence2
Explore how UBRELVY can help patients manage migraine pain.
Clinical evidence2
ZERO MIGRAINE PAIN, SUSTAINED1,2
Co-primary endpoint: Pain freedom at 2 hours without rescue medication1-3*
Limitations: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Therefore, results cannot be regarded as statistically significant.
Secondary endpoint: sustained pain freedom from 2 to 24 hours1,4,5‖
Of patients who achieved pain freedom at Hour 2 (50 mg: 182/886 and 100 mg: 95/448)1:
Across clinical trials: 14% of patients treated with UBRELVY 50 mg (vs 8% with placebo) and 15% of those taking UBRELVY 100 mg (vs 9% with placebo) achieved pain freedom at 2 hours and remained pain-free at 24 hours1
*Pain freedom was defined as a reduction from moderate/severe headache pain to no pain.1 Pain freedom over time was an additional efficacy endpoint.6 Data collected after rescue medication or second dose was excluded.2
†UBRELVY 100 mg was included only in ACHIEVE I.1
§Pain freedom at 48 hours was a secondary (EU only) endpoint.2
‖Sustained pain freedom from 2 to 24 hours was defined as pain freedom with no administration of either rescue medication or second dose of investigational product, and with no occurrence thereafter of mild, moderate, or severe headache pain during the relevant number of hours after dosing.7
Migraine attacks can be unpredictable; no 2 attacks are the same9
In a substudy of patients who took an optional second dose of UBRELVY 50 mg after 2 hours of pain relief: 55% (50 mg: 41/75) achieved pain freedom with the second dose vs 33% (19/57) with placebo10†
*A second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.1
†Patients who received an initial dose of UBRELVY and requested an optional second dose 2 to 48 hours after the initial dose were re-randomized to either receive placebo or repeat their previous dose of UBRELVY.10,11
Secondary endpoint: Pain relief at 2 hours with a single dose1,2,4,5*
Limitations: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Therefore, results cannot be regarded as statistically significant.
*Pain relief was defined as a reduction in migraine pain from moderate or severe to mild or none postdose.1
†UBRELVY 100 mg was included only in ACHIEVE I.1
*Pain relief was defined as a reduction in migraine pain from moderate or severe to mild or none postdose.1
†UBRELVY 100 mg was included only in ACHIEVE I.1
Objective: To determine whether treatment during the initial phase of the migraine attack, prior to the onset of headache, can attenuate the severity of the headache phase and reduce disability.
Key inclusion criteria2
What if you could treat migraine attacks before headache pain begins?
Primary endpoint: Absence of headache pain of moderate to severe intensity within 24 hours after taking UBRELVY 100 mg during the pre-headache phase (1-6 hours prior to onset of headache)
Limitation: This study evaluated a subset of the migraine population who could reliably predict the onset of a migraine attack (per clinician judgment) within a short time window. Patients should be carefully assessed on their ability to accurately predict the onset of a migraine attack and progression to the headache phase. The 50 mg dose was not assessed. Patients were not allowed to administer a second dose.
*P<0.0001 vs placebo.2
Modified intent-to-treat (mITT)=477 participants. The mITT population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying pre-headache event during the double-blind treatment period.2
Odds ratio 2.09 (95% CI, 1.63-2.69)2
INDICATION
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.
LIMITATIONS OF USE
UBRELVY is not indicated for the preventive treatment of migraine.
SAFETY and TOLERABILITY
The most common TEAEs‡ (≥2% in either group) were nausea (UBRELVY: 5% vs placebo: 3.2%), dizziness (2.4% vs 2.6%), fatigue (2.6% vs 1.5%), and somnolence (2.4% vs 1.1%).2
TEAEs=treatment emergent adverse events
†Odds ratio (95% CI) is based on a generalized linear mixed model with treatment group and treatment period as categorical fixed effects.2
‡TEAEs reflect any adverse events reported within 48 hours after taking UBRELVY or placebo.2
In the ACHIEVE studies:
Additional endpoint: Percentage of patients achieving normal function* at 2, 4, and 8 hours with a single dose2,4,5†
Limitations: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Therefore, results cannot be regarded as statistically significant.
Limitation: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity.
*Patients were asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely
impaired, cannot do all or most things, bed rest may be necessary).4,5
†Data collected after rescue medication or second dose was excluded.2
‡UBRELVY 100 mg was included only in ACHIEVE I.1
UBRELVY is the first acute treatment for migraine to directly block calcitonin gene-related peptide (CGRP).8
UBRELVY CONTINUES TO BE THE MOST PRESCRIBED BRANDED TREATMENT FOR MIGRAINE ATTACKS1,2
As of 01/23.
PRIOR
TRIPTAN USE
CONCOMITANT
PREVENTIVE USE
HISTORY OF
DEPRESSION
HISTORY OF
ANXIETY
CARDIOVASCULAR
RISK
Up next: Learn about the
safety of UBRELVY
CONTRAINDICATIONS
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.
ADVERSE REACTIONS
The most common adverse reactions were nausea (4% vs 2% placebo) and somnolence (3% vs 1% placebo).
DRUG INTERACTIONS
DOSAGE AND ADMINISTRATION
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.
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References: 1. UBRELVY. Package insert. AbbVie Inc; 2023. 2. Data on file. AbbVie Inc. 3. 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. 4. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 5. 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. 6. Goadsby PJ, Blumenfeld AM, Lipton RB, et al. Time course of efficacy of ubrogepant for the acute treatment of migraine: clinical implications. Cephalalgia. 2021;41(5):546-560. 7. Supplement to: Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 8. Allergan receives U.S. FDA approval for UBRELVY for the acute treatment of migraine with or without aura in adults. Press release. Cision PR Newswire. Published December 23, 2019. Accessed April 4, 2023. https://www.multivu.com/players/English/8663051-allergan-ubrelvy-acute-treatment-migraine-fda-approval/ 9. Serrano D, Lipton RB, Scher Al, et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18:101. 10. 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. Poster presented at: 61st Annual Scientific Meeting of the American Headache Society, July 11-14, 2019; Philadelphia, PA. 11. 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(1):141-152.
“Do you have ‘warning signs’ that tell you when a headache is about to start? Describe them for me.”
“Considering all your migraine headaches, what percentage are preceded by prodrome/warning symptoms?”
“After experiencing your prodrome symptoms, how reliably does a headache occur within 1 to 6 hours?*”
After meeting eligibility criteria, randomized patients (n=518) treated 2 separate migraine attacks with pre-headache symptoms (≥7 days apart), one with UBRELVY® 100 mg, and one with placebo. Patients continued to record headache information in the e-diary. The 50 mg dose was not assessed. Patients were not allowed to administer a second dose.
*Reliable identification was defined as at least 75% of the time.1
†Based on the 920 participants who entered e-diary data, and includes a total of 4802 qualifying pre-headache events during the screening period. The number of pre-headache symptoms is not the same as the number of pre-headache qualifying events.1
Reference: 1. Data on file. AbbVie Inc.
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Pre-headache symptoms may include1*:
*Other pre-headache symptoms may include but are not limited to irritability, yawning, increased need to urinate, food cravings, difficulty speaking or reading, nausea, visual disturbances, numbness, and tingling. Pre-headache symptoms vary between individuals and from attack to attack.1
References: 1. The timeline of a migraine attack. American Migraine Foundation. Published January 18, 2018. Accessed April 4, 2023. https://americanmigrainefoundation.org/resource-library/timeline-migraine-attack/ 2. Dodick DW. A phase-by-phase review of migraine pathophysiology. Headache. 2018;58(suppl 1):4-16. 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.
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