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Nurtec ODT Efficacy for Acute TreatmentNurtec ODT Efficacy for Acute TreatmentOne orally disintegrating tablet for rapid and sustained relief1,2Nurtec ODT helps provide patients with rapid relief and ability to function normally2Coprimary endpoints Freedom from pain and MBS1

21.2% of patients on Nurtec ODT achieved migraine pain freedom vs 10.9% on placebo; Δ10.3%* (P<0.001) 

35.1% of patients on Nurtec ODT achieved freedom from MBS vs 26.8% on placebo; Δ8.3%* (P=0.001)

Select secondary endpoints
Pain relief and ability to function normally2,3

36.8% of patients on Nurtec ODT achieved pain relief vs 31.2% on placebo; Δ5.5%* (P=0.0314)

22.3% of patients on Nurtec ODT had the ability to function normally vs 15.8% on placebo; Δ6.4%* (P=0.0025)

Select secondary endpoint Sustained pain relief up to 2 days2,3

From 2–48 hours, 42.2% of patients on Nurtec ODT (n=282/669) had sustained pain relief vs 25.2% on placebo (n=172/682); Δ16.9%* (P<0.0001)

Select secondary endpoint 86% of patients on Nurtec ODT did not need a rescue medication2,3

within 24 hours (n=574/669) vs 71% on placebo (n=483/682); Δ15%* (P<0.0001)

MBS=most bothersome symptom.

Difference from placebo based on Cochran-Mantel-Haenszel method.2

See additional data and study design below
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See additional data and study design below

LoadingSingle dose, lasting relief1,2 Difference from placebo based on Cochran-Mantel-Haenszel method.2Pain relief and freedom from pain were measured on the same scale (a 4-point Likert scale [0=none, 1=mild, 2=moderate, 3=severe]). For both endpoints, initial pain was of moderate to severe intensity. For pain freedom, it was reduced to no intensity; for pain relief, it was reduced to mild or no intensity.2
Nurtec ODT provides patients with quick and sustained ability to function normally2
Ability to function normally
Sustained ability to function normally
Tab Number 3
Tab Number 4
Tab Number 5
Difference from placebo based on Cochran-Mantel-Haenszel method.2
Difference from placebo based on Cochran-Mantel-Haenszel method.2
Patient satisfaction data from the 52-week open-label extension study (N=883)4,5
  • Satisfaction with medication was assessed with the Satisfaction with Medication questionnaire, a 7-point survey of participants' perception of whether they were satisfied with their headache medication. The eDiary was used to evaluate the Satisfaction with Medication questionnaire at baseline and weeks 12, 24, and 52.4,5
Limitation: These data are from a prespecified exploratory endpoint of the open-label long-term safety study. Open-label extension studies tend to select patients who respond favorably to treatment and may have limited generalizability. This study was not powered to determine a treatment effect on patient satisfaction and may represent chance findings. No conclusions can be drawn from this analysis, and results should be interpreted with caution.
CI=confidence interval.Dissatisfied includes patients who responded as somewhat dissatisfied (3.5%), very dissatisfied (1.9%), or completely dissatisfied (0.1%). Risk difference not available for pooled results.4,5
Acute study design overview
Nurtec ODT was evaluated in a multicenter, double-blind, placebo-controlled, randomized study with 1466 total patients to treat a migraine attack of moderate to severe pain intensity.2
Coprimary endpoints at 2 hours postdose1
  • Freedom from pain: defined as a reduction in headache severity from moderate/severe at baseline to no pain
  • Freedom from MBS: defined as absence of the most bothersome migraine-associated symptom (photophobia, phonophobia, or nausea)
Select secondary endpoints at various time points2
  • Pain relief and sustained pain relief‡
  • Ability and sustained ability to function normally§
  • Freedom and sustained freedom from MBS
  • No rescue medication within 24 hours||
CV=cardiovascular; NSAID=nonsteroidal anti-inflammatory drug.Patients with stable CV disease and CV risk factors were permitted. Stable CV disease was defined as no events within the past 6 months. Subjects enrolled were stable with ischemic coronary artery disease (3 rimegepant, 1 placebo), history of stroke or transient ischemic attack (3 rimegepant, 2 placebo), peripheral vascular disease (2 rimegepant, 1 placebo), Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders (1 rimegepant, 1 placebo), and uncontrolled hypertension (1 placebo).6Patients were required to wait until their migraine was of moderate to severe intensity before treating with the study medication.2Pain relief: defined as the reduction in headache pain from moderate/severe (2 or 3) at baseline to mild/no pain (1 or 0).2Ability to function normally: defined as the reduction from mild impairment, severe impairment, or required bedrest (1, 2, or 3) at baseline to normal functioning (0).2Rescue medication: NSAIDs, acetaminophen, and/or antiemetic.2CV=cardiovascular; NSAID=nonsteroidal anti-inflammatory drug.Patients with stable CV disease and CV risk factors were permitted. Stable CV disease was defined as no events within the past 6 months. Subjects enrolled were stable with ischemic coronary artery disease (3 rimegepant, 1 placebo), history of stroke or transient ischemic attack (3 rimegepant, 2 placebo), peripheral vascular disease (2 rimegepant, 1 placebo), Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders (1 rimegepant, 1 placebo), and uncontrolled hypertension (1 placebo).6Patients were required to wait until their migraine was of moderate to severe intensity before treating with the study medication.2Pain relief: defined as the reduction in headache pain from moderate/severe (2 or 3) at baseline to mild/no pain (1 or 0).2Ability to function normally: defined as the reduction from mild impairment, severe impairment, or required bedrest (1, 2, or 3) at baseline to normal functioning (0).2Rescue medication: NSAIDs, acetaminophen, and/or antiemetic.2
Long-term safety studied up to 52 weeks: phase 2/3 open-label study design7 Primary endpoints7
  • Frequency and severity of AEs occurring in ≥5% of treated patients
  • Serious AEs
  • AEs leading to study drug discontinuation
  • Clinically significant laboratory abnormalities
Prespecified exploratory endpoint7
  • Satisfaction with medication
AE=adverse event; EOD=every other day; FDA=US Food and Drug Administration; PRN=as needed; SOC=standard of care.Overall, 51% of the patients enrolled in Study 201 had participated in a previous rimegepant study.7With the exception of triptans and acetaminophen, participants were allowed to take SOC migraine treatment, if needed, during the course of study.7The 4–14 attacks per month treatment arm (n=286) did not utilize the FDA-approved dosing regimen for the acute treatment of migraine with or without aura in adults. This treatment arm was included in the analysis presented in the safety section but was excluded from the presentation of exploratory endpoints.7Have samples of Nurtec ODT delivered to your office Get samples LoadingReferences:Nurtec ODT. Package insert. Pfizer Inc.Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737-745.Data on file. BHV3000-303 Clinical Study Report. Pfizer Inc.Data on file. BHV3000-201. Pfizer Inc. Turner I, Pavlovic JM, Lipton RB, et al. Patient preference, satisfaction, and improved Clinical Global Impression of Change with rimegepant 75 mg for the acute treatment of migraine: results from a long-term open-label safety study (study 201). Poster presented at: American Headache Society 62nd Annual Scientific Meeting; June 13, 2020; virtual. Data on file. RIM 130. Pfizer Inc.Croop R, Berman G, Kudrow D, et al. A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine. Cephalalgia. 2024;44(4):1-11.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. Learn more about preventive treatment View the data Loading 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.