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Efficacy & Safety ProfileEfficacy & Safety ProfileAcutePivotal TrialLong-Term Safety StudyTriptan Unsuitable StudyPreventivePivotal TrialPivotal Open-Label Safety ExtensionPrior Inadequate Response StudyCHALLENGE-MIG StudyDosingAbout NurtecAbout NurtecMechanism of ActionPatient ProfilesAccess & SupportAccess &
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Prescribing InformationIndicationsPatient InformationPatient Website

For the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults1

Acute Treatment of MigraineEfficacy & Safety
Profile

Actor portrayal

Acute Treatment of MigraineEfficacy & Safety Profile

Actor portrayal

 Pivotal TrialFreedom from Pain & MBSAt 2 hours, Nurtec ODT provided freedom from pain and most bothersome symptom1Superiority vs placebo for both coprimary endpoints1-3
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ReferencesCI=confidence interval; MBS=most bothersome symptom.Differences from placebo were calculated using the Cochran-Mantel-Haenszel method.2Rapid ResultsDemonstrated rapid pain relief and the ability to function normally in as soon as 1 hour1,2Help patients experience fast relief
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ReferencesPain intensity was assessed on a 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Pain relief was defined as reduction from moderate to severe baseline pain to mild or no pain following treatment.2Differences from placebo were calculated using the Cochran-Mantel-Haenszel method.2The ability to function normally was assessed on a 4-point scale (normal function=0, mild impairment=1, severe impairment=2, required bedrest=3).2Sustained Results & Rescue MedicationWith just 1 dose, many patients experienced sustained results from 2–48 hours2Pain relief and the ability to function normally were sustained from 2–48 hours2
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 Sustained pain relief in responders at 2 hours2||

86% of patients on Nurtec ODT did not need a rescue medication within 24 hours postdose (n=574/669) vs 71% on placebo (n=483/682); Δ15%# (P<0.0001) (select secondary endpoint)2,3

 86% of patients on Nurtec ODT did not need a rescue medication 

within 24 hours postdose (n=574/669) vs 71% on placebo (n=483/682); Δ15%# (P<0.0001) (select secondary endpoint)2,3

 86% of patients on Nurtec ODT did not need a rescue medication within 24 hours postdose (n=574/669) vs 71% on placebo (n=483/682); Δ15%# (P<0.0001) (select secondary endpoint)2,3ReferencesThe ability to function normally was assessed on a 4-point scale (normal function=0, mild impairment=1, severe impairment=2, required bedrest=3). Sustained normal function was defined as the ability to function normally for the specified time period without the use of rescue medication.2,4Differences from placebo were calculated using the Cochran-Mantel-Haenszel method.2Safety ProfileNurtec ODT was generally well tolerated as acute treatment for migraine2,4
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Most common
AEs in trial 3032		Nurtec ODT
(n=682)		Placebo
(n=693)
Nausea11 (2%)3 (<1%)
Urinary tract infection10 (1%)4 (1%)
Dizziness6 (1%)7 (1%)
  • All AEs reported in the study were mild to moderate2
  • <1% of patients discontinued treatment with Nurtec ODT2
  • The most common AE with acute treatment was nausea (Nurtec ODT 2%; placebo 0.4%)1
  • Not contraindicated in patients with stable cardiovascular disease or risk factors
    • Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Nurtec ODT, in the postmarketing setting1
  • Contraindicated in patients with a hypersensitivity to rimegepant, Nurtec ODT, or any of its components1

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.

The gepant mechanism of action has not been associated with medication overuse headache5
AE=adverse event; CGRP=calcitonin gene-related peptide.Study DesignTrial 303 was the pivotal study for the acute treatment of migraine with Nurtec ODT2,6

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. A tablet form was also assessed in 2 similarly designed studies, and bioequivalence has been established.2,6

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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 and freedom and sustained freedom from pain
  • No rescue medication within 24 hours‡‡
Inclusion criteria2Eligible 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), migraine onset before age 50 years, at least 2 and not more than 8 migraine
attacks of moderate or severe intensity per month, and fewer than 15 days per month with migraine or nonmigraine headache within the past 3 months. 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 3 months before study entry. If all other criteria for inclusion were met, participants with contraindications to triptans could be included.Exclusion criteria2Participants were excluded if they had any medical condition that might interfere with study assessments of efficacy and safety or expose participants to undue risk
of a significant adverse event, as decided by the investigator (case by case). Participants were also excluded if they had been treated for or showed evidence of
alcohol or drug abuse within the past 12 months, had a history of drug or other allergy that made them unsuitable for participation, or had ECG or laboratory test
findings that raised safety or tolerability concerns.ReferencesMBS=most bothersome symptom.||Patients were required to wait until their migraine was of moderate to severe intensity before treating with the study medication.2**Pain relief: defined as a reduction in headache pain from moderate/severe (2 or 3) at baseline to mild/no pain (1 or 0).2††Ability to function normally: defined as the reduction from mild impairment, severe impairment, or required bedrest at baseline to normal functioning.2‡‡Rescue medication: NSAIDs, acetaminophen, and/or an antiemetic.2References: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.Study BHV3000-303. Trial in adult subjects with acute migraines. October 15, 2018. Last update posted: February 16, 2023. https://clinicaltrials.gov/study/NCT03461757?term=NCT03461757&rank=1Ailani J, Burch RC, Robbins MS; on behalf of the Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021-1039.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. Next Loading

Long-Term Safety Study

Acute Treatment of Migraine
See how Nurtec ODT is believed to work.Learn about the scienceLoading
The only orally disintegrating tablet for acute treatment of migraine and preventive treatment of episodic migraine in adults. Explore dosing Loading
Learn more about the long-term safety profile of Nurtec ODT as an acute treatment for migraine. See the resultsLoading
Explore Nurtec ODT's well-studied evidence for the preventive treatment of episodic migraine. Review the data Loading

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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.
Help your patients get started with Nurtec ODT
Ordering samples

For your patients with migraine, providing samples can be a great way to have them get started with their Nurtec ODT treatment. Follow the link below to order.
 


Please be aware that your eligibility to order Nurtec ODT samples on PfizerPro is determined by your
experience prescribing Nurtec ODT within the last 12 months.

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