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Nurtec ODT Efficacy for Preventive Treatment

Powerful prevention without an injection1With Nurtec ODT, patients can experience effective migraine prevention with every-other-day dosing1

Secondary endpoint1,2

≥50% reduction in mean number of moderate or severe migraine days per month during weeks 9–12
49% of patients taking rimegepant 75 mg experienced a reduction in moderate to severe MMDs by ≥50% vs 41% of those on placebo (Δ8%; P=0.044)†
 See full study data below LoadingMMDs=monthly migraine days.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 Difference from placebo based on Cochran-Mantel-Haenszel method.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.

Nominal P value due to failure of a prior prespecified endpoint in hierarchical testing structure.2
 See full study data below LoadingCI=confidence interval.

WMDs week 1

MMDs over time
(16 months)

MMDs at weeks 45–48

Tab Number 4

Tab Number 5

Exploratory post hoc analysis

Mean change from baseline in migraine days at week 1

Post hoc analysis: Patients had ≥1 day of efficacy data in the observation period and ≥1 week (7-day interval) in the double-blind treatment period; weekly migraine frequency in the observation period was computed using the number of migraine days of the 4-week period prorated to 7 days.

Analyzed using a generalized linear mixed-effect model.

Limitations: This analysis was not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.

Source: Lipton RB, Croop R, Jensen CM, et al. Rapid decrease in migraine days with rimegepant: results from a post hoc analysis of a phase 2/3, randomized, double-blind, placebo-controlled trial. Poster presented at: American Headache Society 63rd Annual Scientific Meeting; June 3-6, 2021; virtual.WMDs=weekly migraine days.
Prespecified exploratory endpoint from the open-label extension study
Mean change from baseline in MMDs over 16 months This was an open-label extension phase of a 12-week phase 2/3, randomized, double-blind, placebo-controlled study of rimegepant 75 mg every other day for preventive treatment of migraine. Patients who completed the 12-week double-blind treatment phase could continue to the 52-week open-label extension phase. During the open-label extension phase, patients could take 1 rimegepant 75 mg once every other day for preventive treatment of migraine on scheduled dosing days and 1 rimegepant 75 mg as needed for acute treatment of migraine on a nonscheduled dosing day.Limitations:  These analyses were not tested in hierarchical order or adjusted for multiplicity. Open-label studies tend to select for patients who respond favorably to treatment. Results could represent chance findings.Sources: Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. Published online June 30, 2025. doi:10.1111/head.15002Supplement to: Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. Published online December 15, 2020. doi:10.1016/S0140-6736(20)32544-7 Supplement to: Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. Published online June 30, 2025. doi:10.1111/head.15002DB=double-blind; OLE=open-label extension; OP=observation phase; PBO=placebo; RIM=rimegepant.Includes randomized participants who received ≥1 dose of DB study drug and had ≥14 days of eDiary efficacy data (not necessarily consecutive) in both the OP and ≥1 month (4-week interval) in the DB period.Includes the OLE evaluable efficacy population, which consisted of participants with ≥14 days of eDiary efficacy data (not necessarily consecutive) in both the observation period and ≥1 month (4-week interval) in the OLE. Participants also had to have ≥14 days of eDiary efficacy data (not necessarily consecutive) in a specific month (4-week interval) to be evaluated at that month.
Exploratory endpoint
Reduction from baseline in moderate to severe MMDs during month 12 in the open-label extension phase (N=424)
This was an open-label extension phase of a 12-week phase 2/3, randomized, double-blind, placebo-controlled study of rimegepant 75 mg every other day for preventive treatment of migraine. Patients who completed the 12-week double-blind treatment phase could continue to the 52-week open-label extension phase. During the open-label extension phase, patients could take 1 rimegepant 75 mg once every other day for preventive treatment of migraine on scheduled dosing days and 1 rimegepant 75 mg as needed for acute treatment of migraine on a nonscheduled dosing day. 
Limitations: These analyses were not tested in hierarchical order or adjusted for multiplicity. Open-label studies tend to select for patients who respond favorably to treatment. Results could represent chance findings.
Sources: Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. Published online June 30, 2025. doi:10.1111/head.15002 Supplement to: Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. Published online December 15, 2020. doi:10.1016/S0140-6736(20)32544-7 Supplement to: Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. Published online June 30, 2025. doi:10.1111/head.15002

Patient satisfaction data from the 52-week open-label extension (N=288) (prespecified exploratory endpoint)3,4
  • Satisfaction was assessed with the Satisfaction with Medication questionnaire, which measures patients’ level of satisfaction with rimegepant in the study3

Limitation: 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. No conclusions can be drawn from this analysis.

Patients who were dissatisfied with treatment included patients who were somewhat dissatisfied (1.7% [95% CI: 0.6%–4.1%]), very dissatisfied (0% [95% CI: 0.0%–1.6%]), and completely dissatisfied (0.3% [95% CI: 0.0%–2.1%]).4Pivotal phase 2/3 study: preventive treatment of migraine with rimegepant 75 mg1,2,5,6
Rimegepant 75 mg was evaluated for the preventive treatment of migraine in a multicenter, double-blind, randomized, placebo-controlled clinical trial of 747 patients.1,2

Primary endpoint2

  • Change from baseline in the mean number of total migraine days per month in weeks 9–12

Key secondary endpoint2

  • Number of patients who had a ≥50% reduction in moderate or severe migraine days per month in weeks 9–12
NSAID=nonsteroidal anti-inflammatory drug.Open-label extension of the phase 2/3 study of rimegepant 75 mg for the preventive treatment of migraine2,3,5,7
The safety and tolerability of rimegepant 75 mg were further evaluated in a 52-week open-label extension study that included 603 patients who completed the initial 12-week double-blind treatment phase.7
Safety endpoints7
  • AEs and clinical laboratory test evaluations, including liver function tests

Select prespecified exploratory endpoint3

  • Effect of rimegepant on preference of medication and satisfaction evaluated at weeks 12 and 52
EOD=every other day; PRN=as needed; R=randomized.59 (19.5%) patients treated with rimegepant 75 mg and 77 (25.6%) patients treated with placebo had a history of chronic migraine, as assessed by the site principal investigator according to the International Classification of Headache Disorders, 3rd edition.7Permitted rescue medications during the 12-week double-blind treatment phase included triptans, NSAIDs, acetaminophen up to 1000 mg/day for a maximum of 2 consecutive days (including a fixed combination containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg), baclofen, antiemetics, and muscle relaxants. Rimegepant 75 mg was not permitted as a rescue medication.2This is the number of patients who were randomized and took at least one dose of rimegepant 75 mg. This study evaluated a rimegepant 75 mg tablet formulation that was found to be bioequivalent to rimegepant 75 mg ODT based on a phase 1 study.5Have samples of Nurtec ODT delivered to your office Get samples LoadingReferences:Nurtec ODT. Package insert. Pfizer Inc.Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51-60.Mullin K, Pavlovic JM, Hutchinson S, et al. Medication preference, satisfaction, and clinical improvement among adults receiving long-term treatment with rimegepant for migraine. Poster presented at: American Headache Society 64th Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado and virtual.Data on file. BHV3000-305-065. Pfizer Inc.Croop R, Bhardwaj R, Anderson MS, et al. Bioequivalence of rimegepant, a small molecule CGRP receptor antagonist, administered as an oral tablet, a sublingual orally disintegrating tablet, and a supralingual orally disintegrating tablet: two phase 1 randomized studies in healthy adults. Cephalalgia. 2024;44(2):1-12.Lipton RB, Kudrow D, Smith T, et al. Safety and tolerability of rimegepant every other day for preventive treatment of migraine plus as-needed for acute treatment of migraine: results from a 52-week, open-label extension study. Oral presentation at: American Headache Society 64th Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado and virtual.Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. Published online June 30, 2025. doi:10.1111/head.15002 Learn more about acute treatment View the dataLoading Get the details on savings and support Get savings information Loading

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PP-NNT-USA-4379
INDICATIONSNurtec ODT is indicated in adults for the:
  • acute treatment of migraine with or without aura
  • preventive treatment of episodic migraine

Please click here for full Prescribing Information.
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. Adverse Reactions: The most common adverse reactions for Nurtec ODT vs placebo were nausea (2.7% vs 0.8%) and abdominal pain/dyspepsia (2.4% vs 0.8%). Drug Interactions: Avoid concomitant administration of Nurtec ODT with strong inhibitors of CYP3A4 or strong or moderate inducers of CYP3A. Avoid another dose of Nurtec ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4 or potent inhibitors of P-gp. Use in Specific Populations: Pregnancy: It is not known if Nurtec ODT can harm an unborn baby.
Lactation: The transfer of rimegepant into breast milk is low (<1%). Hepatic impairment: Avoid use of Nurtec ODT in persons with severe hepatic impairment. Renal impairment: Avoid use in patients with end-stage renal disease.IndicationsNurtec ODT is indicated in adults for the:
  • acute treatment of migraine with or without aura
  • preventive treatment of episodic migraine

Please click here for full Prescribing Information.