| Most AEs were mild to moderate through 52 weeks1 | PRN 2-8 (n=1033) | PRN 9-14 (n=481) |
| AEs leading to discontinuation | 24 (2.3%) | 16 (3.3%) |
| AEs reported in ≥2% of patients overall | ||
| Upper respiratory tract infection | 108 (10.5%) | 38 (7.9%) |
| Nasopharyngitis | 72 (7%) | 41 (8.5%) |
| Sinusitis | 57 (5.5%) | 28 (5.8%) |
| Urinary tract infection | 40 (3.9%) | 21 (4.4%) |
| Influenza | 49 (4.7%) | 9 (1.9%) |
| Back pain | 36 (3.5%) | 14 (2.9%) |
| Bronchitis | 35 (3.4%) | 14 (2.9%) |
| Nausea | 33 (3.2%) | 15 (3.1%) |
| Dizziness | 26 (2.5%) | 13 (2.7%) |
| Arthralgia | 25 (2.4%) | 9 (1.9%) |
Primary endpoints:
Frequency of serious AEs, AEs, AEs leading to discontinuation, and laboratory test abnormalities1
In the overall population (N=1800)1†:
- 20% of patients reported AEs related to treatment1
- <3% of patients discontinued treatment due to AEs1
- <1% of patients reported constipation with treatment2,3
- <3% of patients reported serious AEs1
- Accidental overdose, appendicitis, osteoarthritis, and pulmonary embolism (3 patients each [0.2%])1
- Constipation, pneumonia, and sepsis (2 patients each [0.1%])1
Serious AEs related to Nurtec ODT1,4
- 10 (0.6%) serious AEs were considered by the investigator to be related to rimegepant 75 mg (1 possibly related serious AE and 9 unlikely related serious AEs)1,4
- No deaths were reported in this study5
| Using Preventives6 243 (13.5%) | Not Using Preventives6 1557 (86.5%) | |
| Serious AE6 | 11 (4.5%) | 36 (2.3%) |
| AEs leading to discontinuation6 | 11 (4.5%) | 37 (2.4%) |
| AEs reported in ≥2% of patients overall | ||
| Upper respiratory tract infection | 18 (7.4%) | 140 (9.0%) |
| Nasopharyngitis | 19 (7.8%) | 103 (6.6%) |
| Sinusitis | 17 (7.0%) | 75 (4.8%) |
| Urinary tract infection | 13 (5.3%) | 56 (3.6%) |
| Influenza | 7 (2.9%) | 52 (3.3%) |
| Back pain | 13 (5.3%) | 43 (2.8%) |
| Bronchitis | 11 (4.5%) | 42 (2.7%) |
| Nausea | 8 (3.3%) | 43 (2.8%) |
| Dizziness | 8 (3.3%) | 34 (2.2%) |
| Arthralgia | 5 (2.1%) | 31 (2.0%) |
Concomitant preventive medications taken by patients in trial 201 included: anticonvulsants, antidepressants, beta blockers, botulinum toxin, calcium channel antagonists, NSAIDs.6
- Prespecified subgroup analysis from an open-label safety study, not powered to determine differences between groups and should be interpreted with caution
- The concomitant preventive subgroup was relatively small, limiting detection of rare safety events
- While a small subgroup of patients receiving preventive CGRP biologics was included after a protocol amendment, safety data for concomitant use with these agents remain limited
| Number of CV risk factors | |||
| 0 (n=1065) | 1 (n=518) | ≥2 (n=217) | |
| Patients with ≥1 AE | 635 (59.6%) | 318 (61.4%) | 135 (62.2%) |
| AEs leading to discontinuation | 20 (1.9%) | 16 (3.1%) | 12 (5.5%) |
| Serious AEs | 29 (2.7%) | 13 (2.5%) | 5 (2.3%) |
| AEs related to rimegepant 75 mg | 217 (20.4%) | 108 (20.8%) | 35 (16.1%) |
| AEs reported in ≥5% of patients overall | |||
| Upper respiratory tract infection | 98 (9.2%) | 39 (7.5%) | 21 (9.7%) |
| Nasopharyngitis | 71 (6.7%) | 42 (8.1%) | 9 (4.1%) |
| Sinusitis | 58 (5.4%) | 28 (5.4%) | 6 (2.8%) |
- Patients with uncontrolled, unstable, or recently diagnosed CVD were excluded from the study5
- Trial 201 was neither designed nor powered to evaluate major cardiovascular AEs in patients treated with rimegepant 75 mg
- Small subgroup size limits any generalization of the data
| AE, n (%)1,2 | Nurtec ODT1,2 (n=295) | Placebo1,2 (n=290) |
| Any AE AE related to study drug | 37 (12.5%) 10 (3.4%) | 35 (12.1%) 10 (3.4%) |
| Mild AE Moderate AE Severe AE Serious AE¶ | 31 (10.5%) 6 (2.0%) 0 0 | 19 (6.6%) 15 (5.2%) 1 (0.3%) 0 |
| AEs of interest Hypertension Raynaud’s phenomenon | 1 (0.3%) 1 (0.3%) | 0 0 |
Post hoc subgroup analysis: AEs in patients with anxiety and/or depression or SSRI and/or other antidepressant use7¶
| Anxiety (n=417) | Depression (n=426) | SSRI (n=181) | Other Antidepressants (n=195) | |
| Patients with ≥1 AE | 280 (67.1%) | 264 (62%) | 116 (64.1%) | 129 (66.2%) |
| AEs leading to discontinuation | 17 (4.1%) | 13 (3.1%) | 9 (5%) | 6 (3.1%) |
| Serious AEs | 15 (3.6%) | 12 (2.8%) | 6 (3.3%) | 10 (5.1%) |
| AEs related to rimegepant 75 mg | 94 (22.5%) | 84 (19.7%) | 43 (23.8%) | 35 (17.9%) |
| AEs reported in ≥5% of patients overall | ||||
| Upper respiratory tract infection | 44 (10.6%) | 41 (9.6%) | 14 (7.7%) | 20 (10.3%) |
| Nasopharyngitis | 24 (5.8%) | 31 (7.3%) | 9 (5%) | 19 (9.7%) |
| Sinusitis | 24 (5.8%) | 28 (6.6%) | 10 (5.5%) | 10 (5.1%) |
Limitations of the analysis
- The study excluded patients with MDD and other more clinically significant psychiatric disorders7
- Trial 201 was not designed to monitor anxiety or depressive symptoms in patients treated with rimegepant 75 mg7
- Small subgroup size limits any generalization of the data
<5% of patients discontinued rimegepant 75 mg due to AEs over the course of 52 weeks.7
Most AEs in these patient subgroups were mild or moderate7
Patient satisfaction at weeks 12 and 524
Exploratory endpoint: Patients completely satisfied or very satisfied with Nurtec ODT4
 |
Satisfaction was assessed using the 7-category Satisfaction with Medicine questionnaire4
Limitations: These data are from an exploratory endpoint of the open-label long-term safety study, which was not powered to determine a treatment effect on patient satisfaction and may represent chance findings. Open-label extension studies tend to select patients who respond favorably to treatment, should be interpreted with caution, and may have limited generalizability. Comparisons should not be made across time points or patient cohorts. No conclusions can be drawn from this analysis.
Trial 201 evaluated the long-term safety and tolerability profile of rimegepant 75 mg acute treatment1,8,9
Rimegepant 75 mg was evaluated in a phase 2/3, multicenter, long-term, open-label safety study in patients treating migraine attacks as needed for up to 52 weeks1,8,9
 |
In the 2 PRN arms, the average age was 43 years, and the majority of participants were female (~90%); ~14% of PRN arm participants were taking ongoing preventive medication for migraine. Previously prescribed SOC medication (NSAID, aspirin, ibuprofen, acetaminophen [up to 1000 mg/day for a maximum of 2 days at a time], antiemetic, or baclofen) was allowed over the course of the study.1||
Trial 201 also included a preventive treatment arm (n=286), in which patients took rimegepant 75 mg every other day plus up to 1 daily dose as needed on nonscheduled days. Preventive treatment arm data are excluded from this presentation of acute treatment results.1
Inclusion criteria1
Eligible participants included men and women aged 18 years and older with at least a 1-year history of migraine with or without aura according to the criteria of the 3rd edition of the International Classification of Headache Disorders (beta version). Patients were required to have had migraine onset before 50 years of age and migraine attacks lasting an average of 4–72 hours when untreated. Patients were also required to have experienced 2–14 moderate to severe migraine attacks per month in the previous 3 months, as well as 2 or more migraine days requiring treatment during the observation period. Participants had to be able to distinguish migraine attacks from attacks of tension-type and cluster headache, and those taking preventive migraine medication had to be on a stable dose for at least 2 months before study entry. If all other criteria for inclusion were met, participants with contraindications to triptans could be included.
Key exclusion criteria1
Patients were excluded if they had a history of basilar or hemiplegic migraine; HIV disease; uncontrolled, unstable, or recently diagnosed CVD; uncontrolled hypertension or diabetes; or BMI ≥30 kg/m2.
Primary safety endpoints1
- Frequency and severity of AEs occurring in ≥5% of treated patients
- Serious AEs
- AEs leading to study drug discontinuation
- Laboratory test abnormalities
Secondary safety endpoints¹
- Frequency of elevations in ALT or AST >3x ULN with concurrent elevations in total bilirubin >2x ULN
- Frequency and severity of hepatic-related AEs
- Frequency of hepatic-related treatment discontinuations
Exploratory endpoints4
- Treatment satisfaction and preference of medication
Triptan Unsuitable Study