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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

Preventive Treatment of Episodic MigrainePivotal Open-Label Safety Extension1Safety ProfileSafety profile assessed over 52 weeks1Safety profile of long-term treatment with rimegepant 75 mg EOD + PRN1
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Most common AEs in
the trial 305 OLE1,2

 Rimegepant 75 mg
EOD + PRN1,2
(n=603)
AEs reported in ≥2% of patients
Upper respiratory tract infection 43 (7.1%)
Nasopharyngitis 38 (6.3%)
Back pain 26 (4.3%)
Influenza 23 (3.8%)
Urinary tract infection 19 (3.2%)
Sinusitis 18 (3%)
Arthralgia 15 (2.5%)
Exposure data: In the OLE period, approximately two-thirds of participants took more than
14 doses of rimegepant 75 mg per month, with median exposure at 14.4 doses/month.1

Most AEs were mild to moderate1

  • 1% of patients (n=6/603) reported constipation related to treatment with rimegepant 75 mg1
  • 2.8% of patients (17/603) discontinued treatment due to AEs1
  • <3% of patients (n=13/603) reported serious AEs. No SAEs were related to treatment1
AEs=adverse events; EOD=every other day; OLE=open-label extension; PRN=as needed; SAEs=serious adverse events.Mean change from observation period in MMDs of any pain severity over the 16-month treatment period1,3Prespecified exploratory endpoint from the open-label extension phase
Exploratory endpoint: Reduction in MMDs over time with rimegepant 75 mg1,3
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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.

CI=confidence interval; DB=double blind; MMDs=monthly migraine days; OLE=open-label extension; OP=observation phase.*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.3†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.3Percentage of patients with reductions in moderate to severe mean MMDs from baseline at month 123Exploratory endpoint: Reduction from baseline in moderate to severe MMDs at month 12 of the open-label extension phase (N=424)1,3
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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.

MMDs=monthly migraine days; OLE=open-label extension.

Patient satisfaction data from the 52-week open-label extension4Exploratory endpoint: Patients completely satisfied or very satisfied with rimegepant4
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Satisfaction was assessed using the 7-category Satisfaction with Medication scale.5

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.

Study DesignStudy 305 OLE trial design1,6

Total duration: 52 weeks (following the 12-week double-blind pivotal trial)1,6

Rimegepant 75 mg EOD was investigated for the preventive treatment of migraine in a phase 2/3, multicenter, double-blind, randomized, placebo-controlled trial of 747 total patients. Long-term use of rimegepant 75 mg was evaluated in a 52-week open-label extension study for the 603 patients who completed the initial 12-week double-blind treatment phase.7,8

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Primary endpoint1

  • Safety and tolerability through 52 weeks

Select secondary endpoints1

  • AEs and serious AEs
  • AEs leading to treatment discontinuation
  • Hepatic-related AEs and hepatic-related AEs leading to treatment discontinuation

Exploratory efficacy endpoints assessed each month and at week 521

  • Mean change in MMDs from the observation period by pain severity
  • Percentage of patients achieving ≥50%, ≥75%, and 100% reductions in MMDs from the observation period by pain severity
DB=double-blind; EOD=every other day; MMDs=monthly migraine days; NSAIDs=nonsteroidal anti-inflammatory drugs; OLE=open label extension; PRN=as needed.References: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. 2026;66(2):407-416.Blair HA. Rimegepant: a review in the acute treatment and preventive treatment of migraine. CNS Drugs. 2023;37(3):255-265. Published correction appears in CNS Drugs. 2023;37(7):661.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. 2026;66(2):407-416.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 130. Poster presented at: American Headache Society 64th Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado and virtual.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. 2021;397(10268):51-60.Efficacy and safety trial of rimegepant for migraine prevention in adults. ClinicalTrials.gov identifier: NCT03732638. Updated June 7, 2024. Accessed August 18, 2025. https://clinicaltrials.gov/study/NCT03732638Croop 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.Nurtec ODT Package insert. Pfizer Inc.
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Prior Inadequate Response Study

Preventive Treatment of Episodic Migraine
The only orally disintegrating tablet for acute treatment of migraine and preventive treatment of episodic migraine in adults. Explore dosing Loading
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
Read about the efficacy and tolerability of Nurtec ODT in adults with a prior inadequate response to traditional migraine medications. View the resultsLoading
Explore Nurtec ODT’s evidence for the acute treatment of migraine with or without aura.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.
 


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