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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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If you do not see Nurtec ODT on your sample list, come back later and try again. It may not have you on the list because it doesn’t have your history established or your quarterly allocation may have been exhausted—in both cases, the system will update.
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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 MigraineTriptan Unsuitable Study1,2A placebo-controlled study of Nurtec ODT in a population unsuitable for triptan usePain relief and return to normal function endpoints at 2 hours1,2In patients with a history of triptan failure or contraindication1,2
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Pain freedom at 2 hours postdose1

Select secondary endpoint1: 

22.7% of patients on Nurtec ODT (n=65/286) experienced pain freedom vs 7.4% on placebo (n=21/284); Δ15.3%* (P<0.0001)1

Limitations: This study evaluated the efficacy of Nurtec ODT vs placebo for the acute treatment of migraine in a population of patients with contraindication(s) or prior lack of efficacy and/or tolerability to triptans. The results do not imply that rimegepant is superior to triptans. The clinical implications of the study findings may vary, as there are no agreed-upon criteria defining patients with migraine who are “triptan unsuitable.”

*Treatment groups were compared using Mantel-Haenszel risk estimation.1,2†Among participants with any level of functional disability (mild impairment, severe impairment, or requires bedrest) at time of dosing.1Treatment groups were compared using Mantel-Haenszel risk estimation.1,2Among participants with any level of functional disability (mild impairment, severe impairment, or requires bedrest) at time of dosing.1Sustained ResultsIn patients with a history of triptan failure or contraindication1,2Statistically significant sustained pain relief and return to normal function from 2 to 48 hours1,2
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‡Treatment groups were compared using Mantel-Haenszel risk estimation.1,§Among participants with any level of functional disability (mild impairment, severe impairment, or requires bedrest) at time of dosing.2Rescue medicationStatistically significant difference in rescue medication use within 24 hours1,2In patients with a history of triptan failure or contraindication1,2Select secondary endpoint: No rescue medication use within 24 hours postdose2
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Treatment groups were compared using Mantel-Haenszel risk estimation.1,2||Treatment groups were compared using Mantel-Haenszel risk estimation.1,2Safety ProfileNurtec ODT was generally well tolerated in patients with a history of triptan failure or contraindication1,2
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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
Scroll left to view table
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
  • AEs occurring in ≥1% of treatment participants#: nasopharyngitis 1.7% (Nurtec ODT) vs 1.0% (placebo)1,2
  • No serious AEs were reported in the study; most AEs were mild1,2
  • AE frequency was similar across treatments: 12.5% (Nurtec ODT) vs 12.1% (placebo)1,2

Intensity (mild, moderate, severe) is based on the MedDRA preferred term worst AE intensity.1


AE=adverse event; MedDRA=Medical Dictionary for Regulatory Activities.
A serious AE is any event that meets any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a subject who received rimegepant 75 mg, and others.3
#Additional AEs occurred in <1% of patients: upper abdominal pain 0.7% (Nurtec ODT) vs 0.3% (placebo), nausea 0.7% (Nurtec ODT) vs 0.3% (placebo), headache 0.7% (Nurtec ODT) vs 0.3% (placebo), dysmenorrhea 0.7% (Nurtec ODT) vs 0.3% (placebo), dizziness 0.7% (Nurtec ODT) vs 0% (placebo).4Intensity (mild, moderate, severe) is based on the MedDRA preferred term worst AE intensity.1AE=adverse event; MedDRA=Medical Dictionary for Regulatory Activities.A serious AE is any event that meets any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a subject who received rimegepant 75 mg, and others.3Additional AEs occurred in <1% of patients: upper abdominal pain 0.7% (Nurtec ODT) vs 0.3% (placebo), nausea 0.7% (Nurtec ODT) vs 0.3% (placebo), headache 0.7% (Nurtec ODT) vs 0.3% (placebo), dysmenorrhea 0.7% (Nurtec ODT) vs 0.3% (placebo), dizziness 0.7% (Nurtec ODT) vs 0% (placebo).4Study Design

Trial 406: A placebo-controlled study of Nurtec ODT in a population unsuitable for triptan use2**

Scroll left to view table

Limitations: This study evaluated the efficacy of Nurtec ODT vs placebo for the acute treatment of migraine in a population of patients with contraindication(s) or prior lack of efficacy and/or tolerability to triptans. The results do not imply that rimegepant is superior to triptans. The clinical implications of the study findings may vary, as there are no agreed-upon criteria defining patients with migraine who are “triptan unsuitable.”

Key inclusion criteria3
Eligible participants included men and women aged 18 years and older with at least a 1-year history of migraine with or without aura, migraine onset before age 50 years, a history of 4–14 migraine attacks per month, and an average duration of untreated migraine attacks of 4–72 hours. Participants had to be able to distinguish migraine attacks from tension/cluster headaches. Participants on background prophylaxis were also permitted to be included as long as they were stable and it was not a CGRP treatment. Treatment history required unsuitability to triptans, defined as prior treatment failure (due to lack of efficacy or intolerance) to ≥2 triptans or the presence of a documented contraindication.

Key exclusion criteria3
Participants were excluded if they were experiencing medication overuse headache at the time of screening or if they had headaches occurring ≥15 days a month in any of the 3 months prior to the screening visit. Participants were also excluded if they had other pain syndromes or neurologic disorders that may interfere with study assessments of safety or efficacy.

CGRP=calcitonin gene-related peptide; DBT=double-blind treatment.

**Unsuitability for triptans was defined as prior treatment failure (due to lack of efficacy or intolerance) to ≥2 triptans or the presence of a documented contraindication.1,2Endpoints

Triptan unsuitable trial efficacy endpoints

Primary endpoint1,2

  • Pain relief at 2 hours postdose


Select secondary endpoints1,2

  • Rescue medication use within 24 hours postdose
  • Return to normal function at 2 hours postdose
  • Sustained return to normal function from 2-48 hours postdose
  • Sustained pain relief from 2-48 hours postdose


Additional secondary endpoints1,2††

  • Pain freedom (no migraine pain) at 2 hours postdose
  • Sustained return to normal function from 2-24 hours postdose
  • Sustained pain relief from 2-24 hours postdose
  • Sustained pain freedom from 2-24 hours postdose
  • Sustained pain freedom from 2-48 hours postdose
  • Freedom from most bothersome symptom (absence of symptom) at 2 hours postdose
††These secondary endpoint results were excluded from this website. For more information, please contact Medical Information at Pfizer.Definition & History

History of triptan experience in the study population

Triptan unsuitability was defined as: A lack of efficacy or prior intolerance to ≥2 triptans or documented contraindication to the use of triptans, as determined by the study investigator and documented within the medical record2,3

Lack of efficacy: No, unsatisfactory, or inconsistent therapeutic effect (eg, recurrent, incomplete relief of migraine-related symptoms such as pain, nausea, photophobia, and phonophobia at 2 hours postdose or nonsustained relief of symptoms through 24 hours postdose), despite repeated dosing (≥2 attempts) at recommended dose levels3

Prior intolerance, including, but not limited to: Prior triptan-associated medication overuse headache; serotonin syndrome; arrhythmia; chest/throat/neck/jaw pain, tightness, pressure, or heaviness; gastrointestinal ischemia or peripheral vasospastic reaction3

Contraindications, including, but not limited to: Documented hypersensitivity to triptans; history of cardiovascular event, condition, or procedure; uncontrolled hypertension3

History of triptan experience in the study population

Enrolled patients had a history of documented treatment failure with ≥2 triptan medications or documented contraindication to the use of triptans1,2

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References:Ashina M, McAllister P, Ramirez LM, et al. A phase 4 randomized double-blind placebo-controlled study of rimegepant for acute treatment of migraine in adults unsuitable for triptan use. Oral presentation at: American Headache Society 67th Annual Scientific Meeting; June 19-22, 2025; Minneapolis, Minnesota.   Ashina M, McAllister P, Gaul C, et al. Rimegepant for acute treatment of migraine in triptan-unsuitable adults: a randomized, double blind, placebo-controlled phase 4 trial. Cephalalgia. 2025;45(11):3331024251395298Data on file. BHV3000-406 Clinical Protocol. Pfizer Inc.Data on file. BHV3000-406 Top Line Results. Pfizer Inc. Next Loading

Preventive Pivotal Trial

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
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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.

Quarterly allocation

If you do not see Nurtec ODT on your sample list, come back later and try again. It may not have you on the list because it doesn’t have your history established or your quarterly allocation may have been exhausted—in both cases, the system will update.
 PP-NNT-USA-5221