NURTEC® ODT (rimegepant) 14 CLINICAL STUDIES

(rimegepant)

Prescribing Information

14 CLINICAL STUDIES

14.1 Acute Treatment of Migraine

The efficacy of NURTEC ODT for the acute treatment of migraine with and without aura in adults was demonstrated in a randomized, double-blind, placebo-controlled trial: Study 1 (NCT03461757). Patients in the study were randomized to receive 75 mg of NURTEC ODT (N=732) or placebo (N=734). Patients were instructed to treat a migraine of moderate to severe headache pain intensity. Rescue medication (i.e., NSAIDs, acetaminophen, and/or an antiemetic) was allowed 2 hours after the initial treatment. Other forms of rescue medication such as triptans were not allowed within 48 hours of initial treatment. Approximately 14% of patients were taking preventive medications for migraine at baseline. None of the patients in Study 1 were on concomitant preventive medication that act on the CGRP pathway.

The primary efficacy analyses were conducted in patients who treated a migraine with moderate to severe pain. NURTEC ODT 75 mg demonstrated an effect on pain freedom and most bothersome symptom (MBS) freedom at two hours after dosing, compared to placebo. Pain freedom was defined as a reduction of moderate or severe headache pain to no headache pain, and MBS freedom was defined as the absence of the self-identified MBS (i.e., photophobia, phonophobia, or nausea). Among patients who selected an MBS, the most commonly selected symptom was photophobia (54%), followed by nausea (28%), and phonophobia (15%).

In Study 1, the percentage of patients achieving headache pain freedom and MBS freedom two hours after a single dose was statistically significantly greater in patients who received NURTEC ODT compared to those who received placebo (Table 1).

Table 1: Efficacy Endpoints for the Acute Treatment of Migraine in Study 1
	Study 1
	NURTEC ODT 75 mg	Placebo
* n=number of responders/N=number of patients in that treatment group
Pain Free at 2 hours
n/N*	142/669	74/682
% Responders	21.2	10.9
Difference from placebo (%)	10.3
p-value		<0.001
MBS Free at 2 hours
n/N*	235/669	183/682
% Responders	35.1	26.8
Difference from placebo (%)	8.3
p-value		0.001

Figure 1 presents the percentage of patients achieving migraine pain freedom within 2 hours following treatment in Study 1.

Figure 1: Percentage of Patients Achieving Pain Freedom within 2 Hours in Study 1

Figure 2 presents the percentage of patients achieving MBS freedom within 2 hours in Study 1.

Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Study 1

In Study 1, statistically significant effects of NURTEC ODT compared to placebo were demonstrated for the additional efficacy endpoints of pain relief at 2 hours, sustained pain freedom 2-48 hours, use of rescue medication within 24 hours, and the percentage of patients reporting normal function at two hours after dosing (Table 2). Pain relief was defined as a reduction in migraine pain from moderate or severe severity to mild or none. The measurement of the percentage of patients reporting normal function at two hours after dosing was derived from a single item questionnaire, asking patients to select one response on a 4-point scale; normal function, mild impairment, severe impairment, or required bedrest.

Table 2: Additional Acute Treatment of Migraine Efficacy Endpoints in Study 1
	Study 1
	NURTEC ODT 75 mg	Placebo
* n=number of responders/N=number of patients in that treatment group † This analysis includes only the use of NSAIDs, acetaminophen, or antiemetics, within 24 hours post-dose; the use of triptans, or other acute migraine medication, was not allowed.
Pain Relief at 2 hours
n/N*	397/669	295/682
% Responders	59.3	43.3
Difference from placebo	16.1
p-value		<0.001
Sustained Pain Freedom 2-48 hours
n/N*	90/669	37/682
% Responders	13.5	5.4
Difference from placebo	8.0
p-value		<0.001
Use of Rescue Medication within 24 hours†
n/N*	95/669	199/682
% Responders	14.2	29.2
Difference from placebo	-15.0
p-value		<0.001
Percentage of Patients Reporting Normal Function at 2 hours
n/N*	255/669	176/682
% Responders	38.1	25.8
Difference from placebo	12.3
p-value		<0.001

The incidence of photophobia and phonophobia was reduced following administration of NURTEC ODT 75 mg as compared to placebo.

14.2 Preventive Treatment of Episodic Migraine

The efficacy of NURTEC ODT for the preventive treatment of episodic migraine in adults was demonstrated in one randomized, double-blind, placebo-controlled trial of a different oral dosage form of rimegepant (Study 2; NCT03732638).

Study 2 enrolled adult patients with at least a 1-year history of migraine (with or without aura). Patients experienced an average of 10.9 headache days during the 28-day observational period, which included an average of 10.2 migraine days, prior to randomization into the trial. Patients were randomized to receive every other day dosing of rimegepant 75 mg (N=373) or placebo (N=374) for 12 weeks. Patients were allowed to use acute headache treatments (i.e., triptans, NSAIDs, acetaminophen, antiemetics, muscle relaxants, and aspirin) as needed. Approximately 10% of patients were taking one preventive medication for migraine at baseline. The use of a concomitant medication that acts on the CGRP pathway was not permitted for either the acute or preventive treatment of migraine.

The study excluded patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within six months of screening.

The primary efficacy endpoint for Study 2 was the change from baseline in the mean number of monthly migraine days (MMDs) during Weeks 9 through 12 of the double-blind treatment phase.

The percentage of patients who achieved at least a 50% reduction from baseline in moderate to severe MMDs during Weeks 9 through 12 of the double-blind treatment phase compared to placebo was also evaluated. Rimegepant 75 mg dosed every other day demonstrated statistically significant improvements for these efficacy endpoints compared to placebo, as summarized in Table 3.

Table 3: Efficacy Endpoints for the Preventive Treatment of Episodic Migraine in Study 2
	Rimegepant 75 mg Every Other Day	Placebo Every Other Day
Monthly Migraine Days (MMD), Weeks 9-12	N=348	N=347
Change from baseline	-4.3	-3.5
Change from placebo	-0.8
p-value	0.010
≥ 50% Responders (Moderate to Severe MMDs), Weeks 9-12	N=348	N=347
% Responders	49.1	41.5
Difference from placebo	7.6
p-value	0.044

Figure 3: Change from Baseline in Monthly Migraine Days in Study 2a

aLeast-square means and 95% confidence intervals are presented.

Figure 4: Distribution of Change from Baseline in Mean Monthly Migraine Days at Month 3 by Treatment Group in Study 2a

aFigure excludes patients with missing data.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 4/2026

PATIENT INFORMATION

NURTEC® ODT (NUR-tek)

(rimegepant)

orally disintegrating tablets (ODT), for sublingual or oral use

What is NURTEC ODT?

NURTEC ODT is a prescription medicine used in adults for the:

•: acute treatment of migraine attacks with or without aura
•: preventive treatment of episodic migraine

It is not known if NURTEC ODT is safe and effective in children.

Do not take NURTEC ODT if you are:

•: allergic to rimegepant, NURTEC ODT, or any of the ingredients in NURTEC ODT.

See the end of this leaflet for a complete list of ingredients in NURTEC ODT.

Before you take NURTEC ODT, tell your healthcare provider about all of your medical conditions, including if you:

•: have high blood pressure.
•: have circulation problems in your fingers and toes.
•: have liver problems.
•: have kidney problems.
•: are pregnant or plan to become pregnant. It is not known if NURTEC ODT will harm your unborn baby. There is a pregnancy exposure registry for women who take NURTEC ODT during pregnancy. The study is named MONITOR (Migraine Observational NURTEC Pregnancy Registry). A registry is a study. The purpose of this registry is to collect information about your health and the health of your baby. Your healthcare provider can help you enroll in this registry. You may also enroll yourself or get more information about the registry by calling 1-877-366-0324, emailing crgnurtecpregnancyregistry@thermofisher.com, or by visiting nurtecpregnancyregistry.com.
•: are breastfeeding or plan to breastfeed. Very small amounts of NURTEC ODT pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take NURTEC ODT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take NURTEC ODT?

•

Take NURTEC ODT by mouth with or without food.

•

Take NURTEC ODT exactly how your healthcare provider tells you to.

•

For the acute treatment of migraine attacks when they occur, NURTEC ODT can be taken 1 time each day as needed. You should not take more than 1 tablet in 24 hours.

o: It is not known if it is safe to take more than 18 doses of NURTEC ODT in 30 days.

•

For the preventive treatment of episodic migraine, take NURTEC ODT 1 time every other day.

•

To take NURTEC ODT:

o: Use dry hands when opening the blister pack.
o: Peel back the foil covering of one blister and gently remove NURTEC ODT. Do not push NURTEC ODT through the foil.
o: As soon as the blister is opened, remove NURTEC ODT and place on or under the tongue.
o: NURTEC ODT will dissolve and no drink or water is needed.
o: Take NURTEC ODT immediately after opening the blister pack. Do not store NURTEC ODT outside the blister pack for future use.

•

If you take too much NURTEC ODT, go to the nearest emergency room right away.

What are the possible side effects of NURTEC ODT?

NURTEC ODT may cause serious side effects including:

•

Allergic reactions. Allergic reactions, including trouble breathing and rash, can happen after you take NURTEC ODT. This can happen days after you take NURTEC ODT. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction:

o: Swelling of the face, mouth, tongue, or throat
o: Trouble breathing
o: Rash

•

High blood pressure. High blood pressure or worsening of high blood pressure can happen after you take NURTEC ODT. Contact your healthcare provider if you have an increase in blood pressure.

•

Raynaud’s phenomenon. A type of circulation problem can worsen or happen after you take NURTEC ODT. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.

The most common side effect of NURTEC ODT in acute treatment of migraine attacks with or without aura is:

•: nausea

The most common side effects of NURTEC ODT in preventive treatment of episodic migraine are:

•: nausea
•: stomach pain
•: indigestion

These are not the only possible side effects of NURTEC ODT.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800 FDA-1088.

How should I store NURTEC ODT?

•: Store NURTEC ODT in the blister package that it comes in.
•: Store NURTEC ODT at room temperature between 68°F to 77°F (20°C to 25°C).

Keep NURTEC ODT and all medicines out of the reach of children.

General information about the safe and effective use of NURTEC ODT:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NURTEC ODT for a condition for which it was not prescribed. Do not give NURTEC ODT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NURTEC ODT that is written for health professionals.

What are the ingredients in NURTEC ODT?

Active ingredient in NURTEC ODT: rimegepant

Inactive ingredients in NURTEC ODT: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin

For more information, go to www.nurtec.com or call 1-833-4NURTEC.

LAB-1548-6.0

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