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Drug Trials Snapshots: REYVOW

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 REYVOW Package Insert for complete information.

REYVOW (lasmiditan)
Rā – vaü
Elly Lilly and Company
Approval date: October 11, 2019


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

REYVOW 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/or sensitivity to light or sound. Patients who suffer from migraines with aura develop temporary visual or other signs and symptoms shortly before or at the time of headache onset.

How is this drug used?

REYVOW is a tablet taken by mouth, as needed.

What are the benefits of this drug?

A higher percentage of patients who received REYVOW were pain free two hours after the treatment, in comparison to patients who received placebo. Also, a higher percentage of patients who received REYVOW were free of their most bothersome migraine associated symptoms (such as light sensitivity, sound sensitivity, or nausea) two hours after the treatment, 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 evaluated patients in Trials 1 and 2. The primary outcome was the percentage of patients achieving pain freedom and the percentage of patients achieving most bothersome symptom (MBS) freedom 2 hours after treatment.

Figure 4: Percentage of Patients Achieving Migraine Pain Freedom within 2 Hours in Pooled Trials 1 and 2

Table summarizes efficacy results by subgroups.

Figure 5: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Trials 1 and 2

Table summarizes efficacy results by subgroups.

aThe 50 mg arm was only included in Trial 2.

REYVOW Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: REYVOW worked similarly in men and women.
  • Race: REYVOW worked similarly among racial groups.
  • Age: REYVOW worked similarly in patients younger or older than 65 years of age.

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 in each trial by age, sex, and race.

Table 2. Subgroup Efficacy Analyses – Trial 1

Pain Free 2 hours Total Patients Success Count Success Rate Total Patients Success Count Success Rate Total Patients Success Count Success Rate
  Age < Median Age >= Median      
100 mg 241 76 31.54% 257 65 25.29%      
200 mg 251 92 36.65% 252 68 26.98%      
Placebo 249 42 16.87% 272 37 13.91%      
  Sex = Women Sex = Male      
100 mg 402 111 27.61% 96 30 31.25%      
200 mg 424 142 33.49% 79 18 22.78%      
Placebo 441 68 15.42% 74 11 14.86%      
  Race = White Race = Black Race = All Other
100 mg 384 102 26.56% 87 31 35.63% 27 8 29.63%
200 mg 382 122 31.94% 98 32 32.65% 23 6 26.09%
Placebo 414 58 14.01% 86 20 23.26% 15 1 6.67%
MBS Free 2 hours Total Patients Success Count Success Rate Total Patients Success Count Success Rate Total Patients Success Count Success Rate
  Age < Median Age >= Median      
100 mg 229 96 41.92% 235 95 40.43%      
200 mg 234 103 44.02% 233 87 37.34%      
Placebo 231 72 31.17% 249 70 28.11%      
  Sex = Women Sex = Men      
100 mg 374 148 39.57% 90 43 47.78%      
200 mg 396 159 40.15% 71 31 43.66%      
Placebo 413 123 29.78% 67 19 28.36%      
    Race =White Race=Black Race=All Other
100 mg 362 148 40.88% 77 31 40.26% 25 12 48.00%
200 mg 358 151 42.18% 88 31 35.23% 21 8 38.10%
Placebo 389 106 27.25% 79 33 41.77% 12 3 25.00%

Table 3. Subgroup Efficacy Analyses – Trial 2

Pain Free 2 hours Total Patients Success Count Success Rate Total Patients Success Count Success Rate Total Patients Success Count Success Rate
  Age < Median Age >= Median      
50 mg 256 74 28.91% 288 80 27.78%      
100 mg 250 79 31.60% 273 85 31.14%      
200 mg 255 85 33.33% 266 117 43.98%      
Placebo 267 48 17.98% 267 64 23.97%      
  Sex = Women Sex = Male      
50 mg 473 143 30.23% 83 16 19.28%      
100 mg 455 139 30.55% 77 28 36.36%      
200 mg 436 173 39.68% 92 32 34.78%      
Placebo 459 95 20.70% 81 20 24.69%      
  Race = White Race = Black Race = All Other
50 mg 443 117 26.41% 80 30 37.50% 21 7 33.33%
100 mg 428 137 32.01% 77 21 27.27% 18 6 33.33%
200 mg 432 166 38.43% 71 29 40.85% 18 7 38.89%
Placebo 442 85 19.23% 74 23 31.08% 18 4 22.22%
MBS Free 2 hours Total Patients Success Count Success Rate Total Patients Success Count Success Rate Total Patients Success Count Success Rate
  Age < Median Age >= Median      
50 mg 240 91 37.92% 262 114 43.51%      
100 mg 242 107 44.21% 249 109 43.78%      
200 mg 241 115 47.72% 237 118 49.79%      
Placebo 259 78 30.12% 250 91 36.40%      
  Sex = Women Sex = Men      
50 mg 429 182 42.42% 73 23 31.51%      
100 mg 424 181 42.69% 67 35 52.24%      
200 mg 400 197 49.25% 78 36 46.15%      
Placebo 434 142 32.72% 75 27 36.00%      
    Race =White Race=Black Race=All Other
50 mg 410 167 40.73% 71 31 43.66% 21 7 33.33%
100 mg 403 180 44.67% 71 31 43.66% 17 5 29.41%
200 mg 400 196 49.00% 60 30 50.00% 18 7 38.89%
Placebo 420 133 31.67% 71 30 42.25% 18 6 33.33%

FDA Review

What are the possible side effects?

REYVOW may cause significant drowsiness, therefore driving should be avoided until at least 8 hours after taking REYVOW. Other serious side effects include sedation, the potential for medication overuse headache, and serotonin syndrome. Serotonin syndrome is a rare, serious, and potentially life threating condition which may be more likely to occur if REYVOW is used with antidepressants called SSRIs or SNRIs.

The most common side effects of REYVOW are dizziness, fatigue, tingling in extremities (paresthesia), and sleepiness.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes most common adverse reactions that occurred in combined Trials 1 and 2.

Table 4. Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Trials 1 and 2

Adverse Reaction REYVOW 50 mg
N=654
%
REYVOW 100 mg
N=1265
%
REYVOW 200 mg
N=1258
%
Placebo
N=1262
%
Dizziness 9 15 17 3
Fatiguea 4 5 6 1
Paresthesiab 3 7 9 2
Sedationc 6 6 7 2
Nausea and/or Vomiting 3 4 4 2
Muscle Weakness 1 1 2 0

a Fatigue includes the adverse reaction related terms asthenia and malaise.
b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral.
c Sedation includes the adverse reaction related term somnolence.

REYVOW 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 in racial groups with exception of dizziness occurring more frequently in White and Asian patients.
  • Age: The occurrence of overall side effects was similar in patients younger or older than 65 years of age. Dizziness and a larger increase in systolic blood pressure occurred more frequently in patients who were at least 65 years of age compared to patients who were less than 65 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The tables below summarize the occurrence of the most common adverse reactions by subgroup. REYVOW arm includes all patients who received any of the approved doses (50 mg, 100 mg or 200 mg).

Table 5. Adverse Reactions by Sex

Preferred Term Women Men
REYVOW
N = 2656
%
Placebo
N=1070
%
REYVOW
N=521
%
Placebo
N=192
%
Dizziness 14.8 3.0 14.2 2.6
Fatigue 4.0 0.6 2.7 1.0
Nausea 3.5 1.5 2.5 2.1
Paresthesia 6.1 1.3 3.6 2.6
Somnolence 5.8 2.4 4.2 0.5
Vomiting 1.1 0.7 0.4 0

Table 6. Adverse Reactions by Race

Preferred Term White Black or African American Asian Other Multiple American Indian or Alaska Native
REYVOW
N=563
%
Placebo
N=229
%
REYVOW
N=26
%
Placebo
N=5
%
REYVOW
N=46
%
Placebo
N=12
%
REYVOW
N=35
%
Placebo
N=11
%
REYVOW
N=21
%
Placebo
N=6
%
REYVOW
N=2476
%
Placebo
N=995
%
Dizziness 15.8 2.3 9.9 4.8 15.4 0 15.2 16.7 14.3 9.1 9.5 0
Fatigue 4.1 0.8 2.7 0 3.8 0 2.2 0 0 0 4.8 0
Nausea 3.5 1.4 2.8 1.7 3.8 0 2.2 8.3 0 9.1 9.5 0
Paresthesia 6.8 1.6 1.1 1.3 0 0 8.7 0 2.9 0 4.8 0
Somnolence 5.1 2.3 6.0 1.7 15.4 0 10.9 0 11.4 0 9.5 0
Vomiting 1.0 0.8 1.1 0 0 0 0 0 0 0 4.8 0

Table 7. Adverse Reactions by Age

Preferred Term Age < 30 years ≥ 30 to <50 years ≥ 50 to <65 years ≥ 65 years
REYVOW Placebo REYVOW Placebo REYVOW Placebo REYVOW Placebo
N = 560 N=234 N=1666 N=639 N=819 N=335 N=132 N=54
% % % % % % % %
Dizziness 17.3 3.8 13.9 3.0 13.8 2.4 18.9 1.9
Fatigue 2.9 0.4 3.8 0.6 4.6 0.6 2.3 1.9
Nausea 3.6 1.3 3.2 2.0 3.7 0.6 3.0 3.7
Paresthesia 3.8 0.9 5.2 1.4 7.6 1.8 7.6 3.7
Somnolence 5.7 0.9 5.5 2.5 5.9 2.7 2.3 0
Vomiting 0.7 0.9 1.3 0.6 0.6 0.6 0.8 0

FDA Review

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved REYVOW primarily based on data from 2 clinical trials, Trial 1 (# NCT02439320) and Trial 2 (#NCT02605174) of 4439 patients with migraine headaches with or without aura. Trials were conducted at 224 sites in the United States, the United Kingdom, and Germany.

Demographics of patients who provided data for evaluation of efficacy are presented in Tables 9 and 10 under MORE INFO.

Demographics of patients who provided data for evaluation of side effects (safety population) are presented below.

Figure 1 summarizes how many men and women were in the clinical trials used to evaluate safety.

Figure 1. Baseline Demographics by Sex (safety population)

Pie chart summarizing how many men and women were in the clinical trial. In total, 3726 women (84%) and 713 men (16%) participated in the clinical trial.

FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trials used to evaluate safety.

Figure 2. Baseline Demographics by Race (safety population)

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 3471 White (78%), 792 Black or African American (18%), 31 Asian (1%), 46 Multiple (1%) and 99 Other (2%).

 

Table 1. Demographics of Safety Trials by Race

Race Number of Patients Percentage of Patients
White 3471 78
Black or African American 792 18
Asian 31 1
American Indian or Alaska Native 27 1
Native Hawaiian or other Pacific Islander 13 Less than 1
Multiple 46 1
Other 59 1

FDA Review

Figure 3. Baseline Demographics by Age (safety population)

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total, 794 patients (18%) were 18-29 years, 2305 patients were 30 – 49 years (52%), 1154 patients (26%) were 50 - 64 years and 186 patients (4%) were 65 years and older).

FDA Review

Who participated in the trials?

Demographic data for the safety population is presented in Table 8, and data for efficacy populations of individual Trials 1 and 2 in Tables 9 and 10, respectively.

Table 8. Demographic Characteristics (safety population)

Demographic Parameters Placebo REYVOW TOTALa
  N=1262 n (%) 50 mg N=654 n (%) 100 mg N=1265 n (%) 200 mg N=1258 n (%) N=4439 n (%)
Sex
Men 192 (15.2) 100 (15.3) 214 (16.9) 207 (16.5) 713 (16.1)
Women 1070 (84.8) 554 (84.7) 1051 (83.1) 1051 (83.6) 3726 (83.9)
Race
White 995 (78.8) 524 (80.1) 980 (77.5) 972 (77.3) 3471 (78.2)
Black or African American 229 (18.1) 106 (16.2) 226 (17.9) 231 (18.4) 792 (17.8)
Asian 5 (0.4) 5 (0.8) 10 (0.8) 11 (0.9) 31 (0.7)
American Indian or Alaska Native 6 (0.5) 3 (0.5) 9 (0.7) 9 (0.7) 27 (0.6)
Native Hawaiian or other Pacific Islander 4 (0.3) 2 (0.3) 2 (0.2) 5 (0.4) 13 (0.3)
Multiple 11 (0.9) 8 (1.2) 16 (1.3) 11 (0.9)/td> 46 (1.0)
Other 12 (1.0) 6 (0.9) 22 (1.7) 18 (1.4) 58 (1.3)
Age
Mean years (SD) 42.5 (12.6) 42.8 (13.2) 42.8 (12.2) 41.6 (12.2) 42.4 (12.5)
Median (years) 43 42 43 41 42
Min, max (years) 18, 79 18, 77 18, 78 18, 81 18, 81
Age Group (years)
18-29 234 (18.5) 119 (18.2) 206 (16.3) 235 (18.7) 794 (17.9)
30-49 639 (50.6) 315 (48.2) 669 (52.9) 682 (54.2) 2305 (51.9)
50-64 335 (26.6) 182 (27.8) 343 (27.1) 294 (23.4) 1154 (26.0)
≥65 54 (4.3) 38 (5.8) 47 (3.7) 47 (3.7) 186 (4.2)
Ethnicity
Hispanic or Latino 208 (16.5) 135 (20.6) 219 (17.3) 213 (16.9) 775 (17.5)
Not Hispanic or
Latino
1047 (83.0) 515 (78.7) 1037 (82.0) 1038 (82.5) 3637 (81.9)
Region
United States 1156 (91.6) 542 (82.9) 1161 (91.8) 1151 (91.5) 4010 (90.3)
Germany and UK 106 (8.4) 112 (17.1) 104 (8.2) 107 (8.5) 429 (9.7)

FDA Review

Table 9. Demographic Characteristics (Trial 1- efficacy population)

  REYVOW
100 mg
N=498
REYVOW
200 mg
N=503
Placebo
N=515
TOTAL
N=1516
Sex, n (%)
Women 402 (80.72%) 424 (84.29%) 441 (85.63%) 1267 (83.6%)
Men 96 (19.28%) 79 (15.71%) 74 (14.37%) 249 (16.4%)
Race, n (%)
American Indian or Alaska Native 4 (0.80%) 5 (0.99%) 1 (0.19%) 10 (0.66%)
Asian 2 (0.40%) 2 (0.40%) 2 (0.39%) 6 (0.40%)
Black or African American 87 (17.47%) 98 (19.48%) 86 (16.70%) 271 (17.88%)
Native Hawaiian or other Pacific Islander 1 (0.20%) 2 (0.40%) 1 (0.19%) 4 (0.26%)
White 384 (77.11%) 382 (75.94%) 414 (80.39%) 1180 (77.84%)
Other 10 (2.01%) 9 (1.79%) 6 (1.17%) 25 (1.65%)
Multiple 10 (2.01%) 5 (0.99%) 5 (0.97%) 20 (1.32%)
Age (years), n
Mean (SD) 42.06 (11.59) 41.28 (12.08) 42.01 (12.44) 41.79 (12.04)
Median 42.0 41.0 42.0 41.00
Minimum 18 18 18 18
Maximum 74 72 78 78

Table 10. Demographic Characteristics (Trial 2- efficacy population)

  REYVOW
50 mg N=544
REYVOW
100 mg
N=523
REYVOW
200 mg N=521
Placebo N=534 TOTAL N=2122
Sex, n (%)
Women 462 (84.93%) 448 (85.66%) 431 (82.73%) 454(85.02%) 1795 (84.59%)
Men 82(15.07%) 75 (14.34%) 90 (17.27%) 80(14.98%) 327(15.41%)
Race, n (%)
American Indian or Alaska Native 3(0.55%) 2(0.38%) 0 5 (0.94%) 10 (0.47%)
Asian 5(0.92%) 5 (0.96%) 7 (1.35%) 3 (0.56%) 20 (0.94%)
Black or African American 80 (14.71%) 77 (14.72%) 71 (13.65%) 74 (13.86%) 302 (14.24%)
Native Hawaiian or other Pacific Islander 2(0.37%) 0 2 (0.38%) 2 (0.37%) 6 (0.28%)
White 443 (81.43%) 428 (81.84%) 432 (83.08%) 442 (82.77%) 1745 (82.27%)
Other 4(0.74%) 6 (1.15%) 4 (0.77%) 3 (0.56%) 17 (0.80%)
Multiple 7(1.29%) 5 (0.96%) 4 (0.77%) 5 (0.94%) 21 (0.99%)
Age (years), n
Mean (SD) 42.82(13.28) 42.54 (12.33) 41.75 (12.22) 42.80 (12.74) 42.72 (12.66)
Median 42 44.0 42.0 42.5 43.00
Minimum 18 18 18 18 18
Maximum 77 77 79 77 79

FDA Review

How were the trials designed?

The FDA approved REVYOW based primarily on data from two clinical trials of adult patients with a history of migraine with or without aura.

The design of Trials 1 and 2 was similar. Adult patients with migraine were assigned to receive one of two (Trial 1) or three (Trial 2) doses of REYVOW or placebo within 4 hours of the onset of a moderate to severe migraine attack. Patients had to report on the status of their pain and their associated migraine symptoms (including light or sound sensitivity or nausea). Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.

The benefit of REYVOW 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.

Patients who completed Trials 1 and 2 could enroll in one additional trial. They were randomized to either 100 mg or 200 mg of REYVOW and could treat all migraine attacks for up to 12 months. The data from this trial were used to assess the long-term side effects of REYVOW.

How were the trials designed?

The efficacy of REYVOW in the acute treatment of migraine was evaluated in two randomized, double-blind, placebo-controlled trials which enrolled adult patients with a history of migraine with and without aura.

The primary efficacy analyses were conducted in patients who treated a migraine of moderate to severe intensity within 4 hours of the onset of the attack. The efficacy of REYVOW was assessed on pain freedom at 2 hours and MBS freedom at 2 hours after dosing compared to placebo. Pain freedom was defined as a reduction of moderate or severe headache pain to no pain, and MBS freedom was defined as the absence of the self-identified MBS (photophobia, phonophobia, or nausea).

Patients who completed the first two trials were eligible to enter the long-term open-label safety trial. Patients were able to take REYVOW intermittently as needed for migraine attacks for up to 12 months w (either 100 mg or 200 mg).

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.

PRESCRIBING INFORMATION

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