Drug Trials Snapshots: UBRELVY
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the UBRELVY Package Insert for complete information.
UBRELVY (ubrogepant)
you-brel-vee
Allergan
Approval date: December 23, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
UBRELVY is a drug used for the acute treatment of migraine with or without aura in adults.
A migraine is a type of headache that, in addition to pain, can be associated with nausea, vomiting, and sensitivity to light or sound. Some patients may experience an aura, which may consist of temporary visual, or other symptoms, shortly before the onset of the headache.
How is this drug used?
UBRELVY is a tablet taken by mouth as needed. A second tablet may be taken two hours after the first one, if needed.
What are the benefits of this drug?
A higher percentage of patients did not have a headache two hours after taking UBRELVY compared to patients who took a placebo. Also, a higher percentage of patients who took UBRELVY did not have their most bothersome migraine-associated symptom (e.g., light sensitivity, sound sensitivity, or nausea) two hours after taking the drug, in comparison to patients who received placebo.
What are the benefits of this drug (results of trials used to assess efficacy)?
The figures below summarize efficacy results for the pooled patients from Trials 1 and 2. The primary outcome measures were pain freedom and most bothersome symptom (MBS) freedom at 2 hours post-dose.
Figure 4. Percentage of Patients Achieving Pain Freedom within 2 Hours in Pooled Trials 1 and 2
a The 100 mg arm was only included in Trial 1.
Figure 5. Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Trials 1 and 2
a The 100 mg arm was only included in Trial 1
UBRELVY Prescribing Information
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: UBRELVY worked similarly in men and women.
- Race: UBRELVY worked similarly across racial groups.
- Age: UBRELVY worked similarly among patients younger and older than 40 years of age. The number of patients 65 years and older was limited; therefore, differences in how UBRELVY worked between patients younger and older than 65 years of age could not be determined.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
The tables below summarize efficacy results by sex, race and age in individual trials.
Table 2. Analyses of Subgroup Populations – Trial 1
FDA Statistical Review.
Table 3. Analyses of Subgroup Populations – Trial 2
FDA Statistical Review
What are the possible side effects?
The most common side effects of UBRELVY are nausea and sleepiness.
What are the possible side effects (results of trials used to assess safety)?
The table below summarizes adverse reactions in adult patients with migraine headaches in the safety population defined as all patients who took at least one dose of UBREVLY or placebo.
Table 8. Adverse Reactions Occurring in At Least 2% and at a Frequency Greater than Placebo in Trials 1 and 2
|
|
UBRELVY |
UBRELVY |
Placebo (N= 984) |
|
Nausea |
2 |
4 |
2 |
|
Somnolence* |
2 |
3 |
1 |
|
Dry Mouth |
<1 |
2 |
1 |
*Somnolence includes the adverse reaction related terms sedation and fatigue.
UBRELVY Prescribing Information
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in men and women.
- Race: The occurrence of side effects was similar across racial groups.
- Age: The occurrence of side effects was similar among patients younger and older than 40 years of age. The number of patients 65 years and older was limited; therefore, differences in side effects between patients younger and older than 65 years of age could not be determined.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
The table below summarizes the occurrence of adverse events by subgroup. This analysis represents patients who received at least a single dose of ubrogepant during drug development program.
Table 9. Adverse Events by Subgroups
|
|
Sex |
Race |
Age |
||||
|
|
Men |
Women |
White |
Black or AA |
Asian |
< 40 years |
≥ 40 years |
|
Patients with Any Adverse Event |
87 |
850 |
798 |
118 |
9 |
416 |
521 |
Adapted from Clinical Review
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved UBRELVY based on evidence from two clinical trials (Trial 1/NCT02828020 and Trial 2/NCT02867709) of 2423 patients with migraine headaches. Trials were conducted at 188 sites in the United States.
Figure 1 summarizes how many men and women were in the clinical trials.
Figure 1. Demographics by Sex (safety population)
Adapted from FDA Clinical Review
Figure 2 summarizes the percentage of patients by race in the clinical trials.
Figure 2. Demographics by Race (safety population)
* All Other includes American Indian or Native Alaskan, and Native Hawaiian or Other Pacific Islander
Adapted from FDA Clinical Review
Figure 3 summarizes the percentage of patients by age in the clinical trials
Figure 3. Demographics by Age (safety population)
Adapted from FDA Review
Who participated in the trials?
The tables below summarize the demographics of the safety population.
Table 10. Demographics of the Safety Population
|
Demographic Parameters |
UBRELVY |
Placebo |
Total |
|
|
50 mg N=954 |
100 mg N=485 |
N=984 |
N=2423 |
|
|
Sex |
|
|
|
|
|
Men |
92 (9.6) |
67 (13.8) |
112 (11.4) |
271 (11.2) |
|
Women |
862 (90.4) |
418 (86.2) |
872 (88.6) |
2152 (88.8) |
|
Race |
|
|
|
|
|
White |
781 (81.9) |
392 (80.8) |
809 (82.2) |
1982 (81.8) |
|
Black or African American |
148 (15.5) |
75 (15.5) |
139 (14.1) |
362 (14.9) |
|
Asian |
9 (0.9) |
7 (1.4) |
16 (1.6) |
32 (1.3) |
|
American Indian or Alaska Native |
5 (0.5) |
4 (0.8) |
6 (0.6) |
15 (0.6) |
|
Native Hawaiian or Other Pacific Islander |
2 (0.2) |
4 (0.8) |
3 (0.3) |
9 (0.4) |
|
Multiple |
9 (0.9) |
3 (0.6) |
11 (1.1) |
23 (0.9) |
|
Age |
|
|
|
|
|
Mean years (SD) |
40.7 (12.1) |
40.6 (12.0) |
41.3 (11.9) |
40.9 (12 |
|
Median (years) |
40.0 |
40.0 |
41.0 |
40.0 |
|
Min, max (years) |
18, 75 |
18, 75 |
18, 74 |
18,75 |
|
Age Group |
|
|
|
|
|
18 to 40 years |
491 (51.5) |
245 (50.5) |
491 (49.9) |
1227 (50.6) |
|
41 to 64 years |
431 (45.2) |
225 (46.4) |
468 (47.6) |
1124 (46.4) |
|
65 to 75 years |
32 (3.3) |
15 (3.1) |
25 (2.5) |
72 (2.9) |
|
Ethnicity |
|
|
|
|
|
Hispanic or Latino |
162 (17.0) |
56 (11.5) |
152 (15.4) |
370 (15.3) |
|
Not Hispanic or Latino |
792 (83.0) |
429 (88.5) |
832 (84.6) |
2053 (84.7) |
|
Region |
|
|
|
|
|
United States |
954 (100) |
485 (100) |
984 (100) |
2423 (100) |
Adapted from FDA Review
How were the trials designed?
The efficacy and safety of UBRELVY were evaluated in two trials of patients with migraine headache with or without aura.
Patients were instructed to treat moderate to severe migraine headache pain with one dose of UBRELVY or placebo. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed. A second dose of the same medication or the patient’s usual treatment for migraine was allowed between 2 to 48 hours after the initial treatment.
The benefit of UBRELVY was assessed based on the percentage of patients who became pain free within 2 hours and comparing it with placebo treated patients. The assessment also included the percentage of patients who were free of their associated most bothersome migraine symptom within 2 hours of taking the trial drug.
How were the trials designed?
The efficacy and safety of UBRELVY were evaluated in two randomized, placebo controlled, double blind trials of patients with migraine headaches with or without aura.
Patients were instructed to treat a migraine with moderate to severe headache pain intensity with one dose of trial medication (UBRELVY or placebo). A second dose of trial medication or the patient’s usual acute treatment for migraine, was allowed between 2 to 48 hours after the initial treatment for a non-responding or recurrent migraine headache.
The primary efficacy endpoints were identical for both trials: pain freedom and most bothersome symptom (MBS) freedom at 2 hours post-dose.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.