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.
POWERFUL
Zero pain, sustained1,2
RAPID
Quick pain relief1
PRE-HEADACHE
Clinical evidence2
POWERFUL
ZERO MIGRAINE PAIN, SUSTAINED1,2
One dose of UBRELVY delivered zero migraine pain for the majority of patients at Hours 4 and 82
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.
ZERO MIGRAINE PAIN SUSTAINED FROM 2 HOURS THROUGH 24 AND 48 HOURS1,2§
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:
- At 24 hours: 70% (50 mg: 119/171) and 77% (100 mg: 68/88) sustained zero migraine pain2
- At 48 hours: 60% (50 mg: 96/159) and 72% (100 mg: 62/86) sustained zero migraine pain2§
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
UBRELVY IS THE ONLY GEPANT WITH AN OPTIONAL SECOND DOSE1,8*
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
About 40% of patients achieved pain relief at 1 hour—and more than 60% at 2 hours1,2,6
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.
HELP PATIENTS QUICKLY ACHIEVE MIGRAINE PAIN RELIEF1
*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
UBRELVY is an
immediate-release tablet that
is rapidly dissolved and
pharmacologically active
within minutes2-4
PRE-HEADACHE
CLINICAL TRIAL
FOR PATIENTS WITH MIGRAINE WHO RECOGNIZE PRE-HEADACHE SYMPTOMS OF A MIGRAINE ATTACK 1 TO 6 HOURS BEFORE THE HEADACHE PHASE2
Since approval, UBRELVY is most prescribed in its class11
Phase 3, multicenter, randomized, double-blind, placebo-controlled crossover study2
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
- Patients between 18 and 75 years of age with ≥1 year history of migraine (with or without aura)
- Occurrence of 2 to 8 migraine attacks/month with moderate to severe headache
What if you could treat migraine attacks before headache pain begins?
Primary results2
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
PATIENTS WHO TOOK UBRELVY 100 mg WERE 2.1x MORE LIKELY TO AVOID HEADACHE PAIN OF MODERATE TO SEVERE INTENSITY (VS PLACEBO) WITHIN 24 HOURS AFTER DOSING2†
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:
RETURN TO FUNCTION
A majority of patients achieved normal function at 2, 4, and 8 hours3
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.
UBRELVY HELPED THE MAJORITY OF PATIENTS GET BACK TO NORMAL FUNCTION2
- At 2 hours, 64% (100 mg: 125/196) and 60% (50 mg: 228/383) of patients taking UBRELVY achieved normal function compared with 54% (139/258) taking placebo2
- At 4 hours, 81% (100 mg: 158/196) and 77% (50 mg: 295/383) of patients taking UBRELVY achieved normal function compared with 67% (172/258) taking placebo2
- At 8 hours, 91% (100 mg: 179/196) and 87% (50 mg: 334/384) of patients taking UBRELVY achieved normal function compared with 76% (195/258) taking placebo2
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 works differently
UBRELVY is the first acute treatment for migraine to directly block calcitonin gene-related peptide (CGRP).8
PROVEN
WELL ESTABLISHED IN MARKET
UBRELVY CONTINUES TO BE THE MOST PRESCRIBED BRANDED TREATMENT FOR MIGRAINE ATTACKS1,2
Since approval, UBRELVY is most prescribed in its class11
As of 01/23.
Every patient is different—the ACHIEVE studies included a diverse patient population,
including those with2,5:
Every patient is
different—the ACHIEVE studies
included a diverse patient
population, including those
with2,5:
PRIOR
TRIPTAN USE
CONCOMITANT
PREVENTIVE USE
HISTORY OF
DEPRESSION
HISTORY OF
ANXIETY
CARDIOVASCULAR
RISK
Up next: Learn about the
safety of UBRELVY
