WHEN IT COMES TO UBRELVY® FOR THE ACUTE TREATMENT OF MIGRAINE, THE PROOF IS IN THE DATA1
PIVOTAL TRIAL RESULTS
RESULTS AT 2 HOURS POSTDOSE WITH UBRELVY
POWERFUL, RAPID EFFICACY1,2
Co-primary endpoint:
Pain freedom at 2 hours with a single dose1,3*
PAIN
FREEDOM
21%
of patients
100 mg (95/448) vs 12% placebo (54/456)1,2†
Secondary endpoint:
Pain relief at 2 hours with a single dose1,4‡
PAIN
RELIEF
61%
of patients
100 mg (275/448) vs 49% placebo (224/456)1†
Additional endpoint:
Normal function§ at 2 hours with a single dose2,4
NORMAL
FUNCTION
64%
of patients
100 mg (125/196) vs 54% placebo (60/122)2
†P<0.05.1
Limitation: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Therefore, results cannot be regarded as statistically significant.
Data presented above is in reference to UBRELVY 100 mg only. See similar results for patients taking UBRELVY 50 mg.2,5
See ACHIEVE Pivotal Trials Design pop-up for more detail, including additional co-primary endpoint data.
*Pain freedom was defined as a reduction from moderate or severe headache pain to no pain.1
†Pain relief was defined as a reduction in migraine pain from moderate or severe to mild or none postdose.1
§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).6
RESULTS AT 4 HOURS POSTDOSE WITH UBRELVY®
Additional endpoint:
Pain freedom at 4 hours with a single dose2*†
PAIN
FREEDOM
71%
of patients
100 mg (140/196) vs 59% placebo (72/122)2
Additional endpoint:
Pain relief at 4 hours with a single dose2†‡
PAIN
RELIEF
85%
of patients
100 mg (382/448) vs 65% placebo (298/456)2
Additional endpoint:
Normal function§ at 4 hours with a single dose2,4†
NORMAL
FUNCTION
81%
of patients
100 mg (158/196) vs 63% placebo (77/122)2
Limitation: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Therefore, results cannot be regarded as statistically significant.
Data presented above is in reference to UBRELVY 100 mg only. See similar results for patients taking UBRELVY 50 mg.2
See ACHIEVE Pivotal Trials Design pop-up for more detail, including additional co-primary endpoint data.
*Pain freedom was defined as a reduction from moderate or severe headache pain to no pain.1
†Censored to exclude data collected after second dose or rescue medication.2
‡Pain relief was defined as a reduction in migraine pain from moderate or severe to mild or none postdose.1
§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).6
SUSTAINED PAIN FREEDOM DATA WITH UBRELVY®1
Secondary endpoint: Sustained pain freedom from 2 through 24 hours1,4*
In a pivotal clinical trial, 15% of patients achieved pain freedom at 2 hours and remained pain-free through 24 hours with UBRELVY 100 mg (vs 9% with placebo).1
IN A SUBSET OF THOSE WHO ACHIEVED PAIN FREEDOM AT HOUR 2 (100 mg: 95/448), AN EXPLORATORY SUBANALYSIS SHOWED1,2:
Limitation: The analyses of exploratory endpoints were not tested in hierarchical order or adjusted for multiplicity. Therefore, results cannot be regarded as statistically significant.
Data presented above is in reference to UBRELVY 100 mg only. See similar results for patients taking UBRELVY 50 mg.2,5
See ACHIEVE Pivotal Trials Design pop-up for more detail, including additional co-primary endpoint data.
*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.6
PRODROME CLINICAL STUDY
DEMONSTRATED DATA FOR TREATMENT EARLY IN THE MIGRAINE ATTACK7
Prodrome symptoms can help patients realize that a migraine attack is underway before headache pain begins.8,9
Prodrome is the occurrence of non-pain migraine symptoms that often occur before aura or headache.8 It can last a few hours to 3 days.9
Common prodrome symptoms include8-10:
- Sensitivity to light
- Neck pain
- Dizziness
- Tiredness
- Sensitivity to sound
When patients took UBRELVY 100 mg early in the migraine attack, in the prodrome phase of migraine (defined in the study as 1-6 hours prior to onset of headache)7:
*P<0.0001 vs placebo.7
mITT=477 participants.7‡
Primary endpoint: Absence of headache pain of moderate to severe intensity within 24 hours after taking UBRELVY 100 mg in the prodrome phase7
Limitation: This study evaluated a subset of the migraine population who could reliably predict the onset of migraine headache pain (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.
Study Design2,7: A phase 3, multicenter, randomized, double-blind, placebo-controlled, crossover study that evaluated the absence of headache pain of moderate to severe intensity within 24 hours postdose after taking a single dose of UBRELVY 100 mg during the prodrome phase. Of the 1087 patients who were screened for eligibility, 290 failed screening due to qualifying event criteria, including investigator judgment. See Prodrome Study Design for additional details.
UBRELVY IS THE ONLY ACUTE TREATMENT FOR MIGRAINE THAT HAS DEMONSTRATED DATA IN THE PRODROME PHASE IN A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL2,7
mITT=modified intent-to-treat.
†Odds ratio (95% CI) was based on a generalized linear mixed model with treatment group and treatment period as categorical fixed effects.7
‡The mITT population consisted 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 prodrome event during the double-blind treatment period.7
Up next: Learn about the safety of UBRELVY
