*Least-square means and 95% CIs are presented. Baseline MMDs during the 4-week baseline observation period were 10.3 for patients taking rimegepant and 9.9 for patients taking placebo.1,2
†Analyzed using a generalized linear mixed-effects model with treatment group, preventive migraine medication use at randomization, study month, and month-by-treatment group interaction as fixed effects and participant as random effect.²
Baseline characteristics reflected a population with substantial burden of disease2
- On average, patients experienced 7.8 moderate to severe attacks per month
- Average duration of untreated attacks was 24 hours
- 40% of patients had migraine with aura
- Nominal P value observed due to failure of a prior prespecified endpoint in hierarchical testing structure.2
- Analyzed using a generalized linear mixed-effects model with treatment group, preventive migraine medication use at randomization, study month, and month-by-treatment group interaction as fixed effects and participant as random effect.2
- Limitations: This analysis was not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.
- Patients had ≥1 day of efficacy data in the observation phase and ≥1 week (7-day interval) in the double-blind treatment phase; weekly migraine frequency in the observation period was computed using the number of migraine days of the 4-week period prorated to 7 days.3
| n (%) | Rimegepant2 (n=370) |
Placebo2 (n=371) |
|---|---|---|
| Participants with any AE2 | 133 (36%) | 133 (36%) |
| AEs in ≥2% of participants Nasopharyngitis Nausea Urinary tract infection Upper respiratory tract infection |
13 (4%) 10 (3%) 9 (2%) 8 (2%) |
9 (2%) 3 (1%) 8 (2%) 10 (3%) |
| Participants with mild AEs | 92 (25%) | 91 (25%) |
| Participants with moderate AEs | 64 (17%) | 62 (17%) |
| Participants with AEs related to treatment | 40 (11%) | 32 (9%) |
| Serious AEs§ | 3 (1%) | 4 (1%) |
| Serious AEs related to treatment | 0% | 1 (<1%) |
| AEs leading to discontinuation | 7 (2%) | 4 (1%) |
- The most common AEs in trial 305 were nasopharyngitis, nausea, urinary tract infection, and upper respiratory tract infection.2
- 2% of patients treated with rimegepant discontinued due to adverse events in the double-blind phase of the pivotal preventive trial2
- Rimegepant was not associated with any serious treatment-related adverse events2§
Select Important Safety Information
Contraindications: Hypersensitivity to Nurtec ODT or any of its components.
Warnings and Precautions
Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included anaphylaxis, dyspnea, and rash and can occur days after administration.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Nurtec ODT, in the postmarketing setting.
Monitor patients for new-onset hypertension or worsening of pre-existing hypertension and consider whether discontinuation is warranted.
Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Nurtec ODT.
If signs or symptoms of Raynaud’s phenomenon develop, discontinue Nurtec ODT. Patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for and informed about the possibility of worsening or recurrence of signs and symptoms.
Phase 2/3, randomized, double-blind, placebo-controlled study that evaluated rimegepant 75 mg as preventive treatment for migraine (N=747)1,2,5
Primary endpoint1
- Change from observation period in mean MMDs in weeks 9–12
Select secondary endpoints2
- Participants with ≥50% reduction in moderate or severe MMDs in weeks 9–12
- Change from observation period in mean MMDs in weeks 1–12
- Change from observation period in mean MMDs in weeks 1–4
Pivotal Open-Label Safety Extension