Drug Trials Snapshots: NURTEC ODT
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 NURTEC ODT Package Insert for complete information.
NURTEC ODT (rimegepant)
NUR-tek ODT
Biohaven Pharmaceutical Inc.
Approval date: February 27, 2020
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
NURTEC ODT is a drug used for treatment of acute 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 a temporary visual disturbance, or other symptoms shortly before the onset of the headache.
How is this drug used?
NURTEC ODT is a tablet taken by mouth once a day, as needed.
What are the benefits of this drug?
A higher percentage of patients did not have a headache two hours after taking NURTEC ODT compared to patients who took a placebo. Also, a higher percentage of patients who took NURTEC ODT did not have their most bothersome migraine-associated symptom (e.g., light sensitivity, nausea, or sound sensitivity) two hours after taking the drug, in comparison to patients who received placebo.
What are the benefits of this drug?
The figures below summarize efficacy results for the patients from Trial 1. The primary outcome measures were pain freedom and most bothersome symptom (MBS) freedom at 2 hours post-dose.
Figure 5. Percentage of Patients Achieving Pain Freedom within 2 Hours in Trial 1
NURTEC ODT Prescribing Information
Figure 6. Percentage of Patients Achieving MBS Freedom within 2 Hours in Trial 1
NURTEC ODT Prescribing Information
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: NURTEC ODT worked similarly in men and women.
- Race: NURTEC ODT worked similarly across racial groups.
- Age: NURTEC ODT 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 NURTEC ODT 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 table below summarizes efficacy results by age, sex, and race in the Trial 1.
Table 1. Analyses of Subgroup Populations – Trial 1
| Pain Free 2 hours | Total Patient | Success Count | Success Rate | Total Patient | Success Count | Success Rate | Total Patient | Success Count | Success Rate |
|---|---|---|---|---|---|---|---|---|---|
| Age < 40 | Age >= 40 | ||||||||
| 75 mg ODT | 341 | 72 | 21.1% | 328 | 70 | 21.4% | |||
| Placebo | 368 | 42 | 11.5% | 314 | 32 | 10.2% | |||
| Sex = Women | Sex= Men | ||||||||
| 75 mg ODT | 568 | 128 | 22.6% | 101 | 14 | 13.9% | |||
| Placebo | 579 | 62 | 10.7% | 103 | 12 | 11.7% | |||
| Race = White | Race = Black | Race = All Other | |||||||
| 75 mg ODT | 496 | 105 | 21.2% | 141 | 33 | 23.3% | 30 | 4 | 13.3% |
| Placebo | 521 | 54 | 10.4% | 125 | 16 | 12.9% | 36 | 4 | 11.1% |
| MBS Free 2 hours | Total Patient | Success Count | Success Rate | Total Patient | Success Count | Success Rate | Total Patient | Success Rate | Success Rate |
|---|---|---|---|---|---|---|---|---|---|
| Age < 40 | Age >= 40 | ||||||||
| 75 mg ODT | 341 | 118 | 34.6% | 328 | 117 | 35.7% | |||
| Placebo | 368 | 103 | 28.0% | 314 | 80 | 25.5% | |||
| Sex = Women | Sex= Men | ||||||||
| 75 mg ODT | 568 | 206 | 36.3% | 101 | 29 | 28.8% | |||
| Placebo | 579 | 161 | 27.8% | 103 | 22 | 21.6% | |||
| Race = White | Race = Black | Race = All Other | |||||||
| 75 mg ODT | 496 | 170 | 34.3% | 141 | 57 | 40.2% | 30 | 8 | 26.7% |
| Placebo | 521 | 135 | 25.9% | 125 | 37 | 29.6% | 36 | 11 | 30.6% |
FDA Statistical Review
What are the possible side effects?
NURTEC ODT may cause severe allergic reactions.
The most common side effect of NURTEC ODT is nausea.
What are the possible side effects?
The most common adverse reaction in Trial 1 was nausea (2% in patients who received NURTEC ODT compared to 0.4% of patients who received placebo).
NURTEC ODT 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 in drug development program by subgroups. Presented is pooled safety population from double-blind trials in which patients received a single dose of rimegepant 75 mg or placebo.
Table 2. Treatment Emergent (TEAEs) by Subgroups in Single-dose Rimegepant Trials
| Subgroup | Rimegepant (N = 1,771) x/n (%) |
Placebo (N = 1,782) x/n (%) |
|---|---|---|
| Sex | ||
| Women | 171/1,526 (11.2) | 136/1,534 (8.9) |
| Men | 21/242 (8.7) | 18/248 (7.3) |
| Race | ||
| White | 138/1,322 (10.4) | 121/1378 (8.8) |
| Black or African-American | 39/365 (10.7) | 26/331 (7.9) |
| Asian | 5/23 (21.7) | 4/34 (11.8) |
| Age (years) | ||
| < 40 | 98/888 (11.0) | 81/896 (9.0) |
| ≥ 40 | 94/883 (10.6) | 73/886 (8.2) |
| < 65 | 187/1,735 (10.8) | 149/1,730 (8.6) |
| ≥ 65 | 5/36 (13.9) | 5/52 (9.6) |
Clinical Trial Data
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the trials?
The FDA approved NURTEC ODT based on evidence from one clinical trial (Trial 1/NCT03461757) of 1351 patients with migraine headaches. Trial was conducted at 69 sites in the United States.
Figure 1 summarizes how many men and women were in the clinical trial.
Figure 1. Demographics by Sex (efficacy population)
Adapted from FDA Statistical Review
Figure 2 summarizes the percentage of patients by race in the clinical trial.
Figure 2. Demographics by Race (efficacy population)
* All Other includes American Indian or Native Alaskan, Multiple and Other
Adapted from FDA Statistical Review
Figure 3 summarizes the percentage of patients by age in the clinical trial.
Figure 3. Demographics by Age (efficacy population)
Adapted from FDA Statistical Review
Figure 4 summarizes the percentage of patients by ethnicity in the clinical trial.
Figure 4. Demographics by Ethnicity (efficacy population)
Adapted from FDA Statistical Review
Who participated in the trials?
The table below summarizes the demographics of the efficacy population.
Table 3. Demographics of the Efficacy Population
| Demographic Parameters | NURTEC ODT N=669 n (%) |
Placebo N=682 n (%) |
TOTAL N=1351 n (%) |
|---|---|---|---|
| Sex | |||
| Men | 101 (15.1) | 103 (15.1) | 204 (15.1) |
| Women | 568 (84.9) | 579 (84.9) | 1147 (84.9) |
| Race | |||
| White | 496 (74.1) | 521 (76.4) | 1017 (75.3) |
| Black or African American | 141 (21.1) | 125 (18.3) | 266 (19.7) |
| Asian | 8 (1.2) | 19 (2.8) | 27 (2) |
| Native Hawaiian or Other Pacific Islander | 11 (1.6) | 5 (0.7) | 16 (1.2) |
| American Indian or Alaska Native | 4 (0.6) | 3 (0.4) | 7 (0.5) |
| Multiple | 7 (1.0) | 9 (1.3) | 16 (1.2) |
| Unknown | 2 (0.3) | 0 | 2 (0.1) |
| Age (years) | |||
| Mean years (SD) | 40.3 (12.1) | 40.0 (11.9) | 40.2 (12) |
| Median (years) | 39.7 | 38.9 | 39.3 |
| Min, max (years) | 18, 76 | 18, 72 | 18,76 |
| Age Group (years) | |||
| 18 to 40 | 352 (52.6) | 385 (56.5) | 737 (54.6) |
| 41 to 64 | 305 (45.7) | 280 (41.1) | 585 (43.3) |
| ≥65 years | 12 (1.9) | 17 (2.6) | 29 (2.1) |
| Ethnicity | |||
| Hispanic or Latino | 116 (17.3) | 135 (19.8) | 251 (18.6) |
| Not Hispanic or Latino | 553 (82.7) | 547 (80.2) | 1100 (81.4) |
| Region | |||
| USA | 669 (100) | 682 (100) | 1351 (100) |
Adapted from FDA Statistical Review
How were the trials designed?
The efficacy and safety of NURTEC ODT were evaluated in one trial of patients with migraine headache with or without aura.
Patients were instructed to treat moderate to severe migraine headache pain with one dose of NURTEC ODT or placebo. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed. Use of other drugs (i.e., Advil, Tylenol, and/or drugs to treat nausea) was allowed 2 hours after the initial treatment.
The benefit of NURTEC ODT 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 most bothersome migraine symptom within 2 hours of taking the trial drug.
How were the trials designed?
The efficacy and safety of NURTEC ODT were evaluated in one randomized, placebo controlled, double blind trial 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 (NURTEC ODT or placebo). Rescue medication (i.e., NSAIDs, acetaminophen, and/or an antiemetic) was allowed 2 hours after the initial treatment.
The primary efficacy endpoints were 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.
PRESCRIBING INFORMATION