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

Nurtec® ODT (rimegepant) Home

For U.S. Healthcare Professionals Only

Efficacy

Allie S.
Actual Nurtec ODT patient.

*Per IQVIA as oral brand in class (oral CGRP receptor antagonists): number one prescribed and number one in new prescriptions, since 8/6/21. Data current as of 8/21/23.

One 75 mg dosage strength to treat and help prevent migraine attacks1

A RAPIDLY DISSOLVING TABLET WITH EFFICACY THAT’S

FAST & LASTS1-3

ACUTE TREATMENT

Delivered freedom from pain and most bothersome symptom (MBS)1
(co-primary endpoints)

At 2 hours after a single dose of Nurtec ODT:

  • 21.2% (142/669) of patients achieved migraine pain freedom vs 10.9% (74/682) on placebo; Δ10.3%* (P<.001)1
  • 35.1% (235/669) achieved freedom from MBS vs 26.8% (183/682) on placebo; Δ8.3%* (P=.001)1

Rapid response at 1 hour2,4
(select secondary endpoints)

At 60 minutes:

  • 36.8% (246/669) of patients on Nurtec ODT achieved pain relief vs 31.2% (213/682) on placebo; Δ5.5%* (P=.0314)2,4
  • 22.3% (149/669) had returned to normal function vs 15.8% (108/682) on placebo; Δ6.4%* (P=.0025)2,4

One dose treats for up to 2 days2,4
(select secondary endpoint)

From 2 to 48 hours:

  • 42.2% (282/669) of patients on Nurtec ODT had sustained pain relief vs 25.2% (172/682) on placebo; Δ16.9%* (P<.0001)2,4

PREVENTIVE TREATMENT

Reduction in monthly migraine days (MMDs)1
(primary endpoint)

During weeks 9 through 12:

  • Patients who took rimegepant every other day (n=348) had a 4.3-day reduction from baseline in mean MMDs vs a 3.5-day reduction in those taking placebo; Δ-0,8%* (n=347) (P=.01)1,†

 

*Difference from placebo based on Cochran-Mantel-Haenszel method.2,3

†Analyzed using a generalized linear mixed-effects model with treatment group, preventive migraine medication use at randomization, study month, and month-by-treatment group interaction as fixed effects and participant as random effect.3

Study designs

Acute Pivotal Trial1,2
Rimegepant 75 mg was evaluated in a multi-center, double-blind, placebo-controlled, randomized study with 1466 total patients to treat a migraine of moderate-to-severe pain intensity. A tablet form was also assessed in 2 similarly designed studies, and bioequivalence has been established. The co-primary endpoints were freedom from pain at 2 hours post-dose and freedom from most bothersome symptom (MBS). Freedom from pain was defined as a reduction in headache severity from moderate/severe at baseline to no pain. Freedom from MBS was defined as absence of the most bothersome migraine-associated symptom (photophobia, phonophobia, or nausea). Select secondary endpoints included pain relief, return to normal function, freedom from MBS and pain, no rescue medication use, sustained freedom from pain, sustained pain relief, and sustained return to normal function. The screening phase included men and women aged 18 years and older with at least a 1-year history of 2 to 8 moderate or severe migraine attacks per month with or without aura. The treatment phase involved 732 patients taking rimegepant 75 mg and 734 patients taking placebo. Approximately 85% of patients were female, 74% were White, 21% were Black, and 17% were Hispanic or Latino. The mean age at study entry was 40 years (range 18-75 years of age). 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.

Preventive Pivotal Trial1,3
Rimegepant 75 mg was evaluated for the preventive treatment of migraine in a multi-center, double-blind, randomized, placebo-controlled clinical trial of 747 patients. The primary endpoint was change from baseline in the mean number of monthly migraine days (MMDs) during weeks 9 through 12. The select secondary endpoint was the percentage of patients who achieved ≥50% reduction in moderate-to-severe MMDs during weeks 9 through 12. The trial was split into 3 phases. The 4-week baseline observation phase included patients with a history of 4 to 18 moderate-to-severe monthly migraine attacks. Patients with ≥6 migraine days and ≤18 headache days were eligible for the 12-week treatment phase, which consisted of 373 patients receiving rimegepant 75 mg ODT and 374 patients receiving placebo, both dosed every other day. Approximately 81% of patients were female, 80% were White, 17% were Black, and 28% were Hispanic or Latino. The mean age at study entry was 41 years (range 18-74 years of age). Permitted rescue medications during the 12-week double-blind treatment phase included triptans, nonsteroidal anti-inflammatory drugs, paracetamol up to 1000 mg/day for a maximum of 2 consecutive days (including a fixed combination containing paracetamol 250 mg, aspirin 250 mg, and caffeine 65 mg), baclofen, antiemetics, and muscle relaxants. Rimegepant was not permitted as a rescue medication.

Improvement over placebo at 2 hours post-dose1

ACUTE TREATMENT OF MIGRAINE ATTACKS1,*

Graph of co-primary and secondary endpoints for Nurtec ODT vs placebo
nearly 60% of patients achieved pain relief in 2 hours, see Safety Info

MBS=most bothersome symptom; predefined as photophobia, phonophobia, or nausea
*Patients using rescue medications at or before the assessment and patients not providing data were classified as treatment failures.2
§Difference from placebo based on Cochran-Mantel-Haenszel method.2,3

Patients on therapy demonstrated a significant reduction in mean monthly migraine days (MMDs)1,*

PREVENTIVE TREATMENT OF EPISODIC MIGRAINE1

REDUCTION IN MMDs1,*
Primary endpoint at weeks 9 through 12

Study data of monthly migraine days during weeks 9 through 12 with Nurtec ODT and placebo, see Safety Info
49% of patients, see Safety Info

Select secondary endpoint
Approximately half (171/348) of patients taking rimegepant every other day decreased their moderate-to-severe MMDs by ≥50% vs 42% (144/347) of those taking placebo; Δ8.0%§ (P=.044)1,3,‡

MMDs=monthly migraine days
*Analyzed using a generalized linear mixed-effects model with treatment group, preventive migraine medication use at randomization, study month, and month-by-treatment group interaction as fixed effects and participant as random effect.3‡Baseline MMDs during the 4-week observation period was 10.3 for rimegepant-treated subjects and 9.9 for placebo-treated subjects.3
§Difference from placebo based on Cochran-Mantel-Haenszel method.2,3

I love that Nurtec ODT can get rid of my migraine pain fast!

Kris W.

Actual Nurtec ODT patient.
Individual results may vary.

Patients were invited to share their experiences on Nurtec ODT. All content was accurate at the time of publication.

ONSET DATA

Acute treatment of migraine attacks1

Return to normal function1,2,4
(select secondary endpoints)

pain relief of Nurtec ODT vs placebo, see Safety Info

PREVENTIVE TREATMENT OF EPISODIC MIGRAINE1

Change in mean number of total migraine days per month during weeks 1-43,*
(select secondary endpoint)

Study data of reduction in weekly migraine days during week 1 of Nurtec ODT and placebo, see Safety Data

Nominal P value due to failure of a prior prespecified endpoint in hierarchical testing structure.3

*Analyzed using a generalized linear mixed-effects model with treatment group, preventive migraine medication use at randomization, study month, and month-by-treatment group interaction as fixed effects and participant as random effect.3


‡Difference from placebo based on Cochran-Mantel-Haenszel method.2,3

DURATION DATA

ACUTE TREATMENT OF MIGRAINE ATTACKS

Sustained response from 2-48 hours1
(select secondary endpoint)

48h

14% of patients taking Nurtec ODT 75 mg (90/669) experienced freedom from pain from 2-48 hours vs 5% of patients taking placebo (37/682); Δ8.0%* P<.0011

  • In a post-hoc subgroup analysis of those who experienced freedom from pain at 2 hours, 63% (90/142) of patients taking Nurtec ODT maintained it through 48 hours vs 50% (37/74) of patients taking placebo.5,†

86%

86% (574/669) of patients in the Nurtec ODT group did not take a rescue medication (including OTCs) within 24 hours post-dose vs 71% (483/682) in the placebo group; Δ15.0%* P≤.0011 (select secondary endpoint)

PREVENTIVE TREATMENT OF EPISODIC MIGRAINE

Reduction in moderate-to-severe monthly migraine days (MMDs) during weeks 9 through 121
(select secondary endpoint)

49%
of patients

Approximately half (171/348) of patients taking rimegepant decreased their moderate‑to‑severe MMDs by ≥50% vs 42% (144/347) of those taking placebo; Δ8.0%* P=.0441,3,‡

A consistent trend in reduction of mean MMDs was shown month over month from 1 to 3 months1

*Difference from placebo based on Cochran-Mantel-Haenszel method.2,3
†Limitation: This analysis was not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.
‡Baseline MMDs during the 4‑week observation period was 10.3 for rimegepant‑treated subjects and 9.9 for placebo‑treated subjects.3

Wow...I placed it on top of my tongue and let it dissolve. One hour later and my migraine was gone. I had no idea something could work so fast!

Mary R.

Actual Nurtec ODT patient.
Individual results may vary.

I get really bad migraines that keep me in bed for days. As soon as I feel a migraine coming, I take Nurtec ODT and it works for me.

Araceli H.

Actual Nurtec ODT patient.
Individual results may vary.

Patients were invited to share their treatment experiences on Nurtec ODT. All content was accurate at the time of publication.

Evaluated in 2 pivotal trials2,3

ACUTE TREATMENT2

Nurtec ODT 75 mg (n=669) vs placebo (n=682)

Co-primary endpoints at 2 hours post-dose2

  • Freedom from pain
  • Freedom from most bothersome symptom (MBS)

Secondary efficacy endpoints2

60 minutes post-dose:

  • Pain relief
  • Ability to function normally

90 minutes post-dose:

  • Pain relief
  • Ability to function normally
  • Freedom from MBS
  • Freedom from pain

2 hours post-dose:

  • Pain relief
  • Ability to function normally
  • Freedom from photophobia
  • Freedom from phonophobia
  • Freedom from nausea

Sustained from 2 to 48 hours post-dose:

  • Pain relief
  • Ability to function normally
  • Freedom from MBS
  • Freedom from pain

2 to 48 hours post-dose:

  • No pain relapse

Sustained from 2 to 24 hours post-dose:

  • Pain relief
  • Ability to function normally
  • Freedom from MBS
  • Freedom from pain

Within 24 hours post-dose:

  • No rescue medication

Exploratory analyses of efficacy outcomes at various timepoints starting at 15 minutes post-dose2,§

PREVENTIVE TREATMENT3,*,†,‡

Rimegepant 75 mg (n=348) vs placebo (n=347)

Primary endpoint during weeks 9 through 123

  • Change from baseline in mean monthly migraine days (MMDs)

Select secondary efficacy endpoints3

  • Percentage of patients who achieved a ≥50% reduction in moderate-to-severe MMDs during weeks 9 through 12
  • Change from baseline in MMDs during weeks 1 through 12
  • Mean number of rescue medication days per month during weeks 9 through 12
  • Change from baseline in MMDs during weeks 1 through 4

Select exploratory analysis6,7,§

  • Mean absolute and percentage changes from baseline in the number of weekly migraine days during week 1

*Patients in the preventive treatment pivotal trial were randomized 1:1 to either rimegepant 75 mg tablets or matching placebo tablets.3
†The ODT and tablet formulations of rimegepant are bioequivalent.2
‡Baseline values observed during a 28-day observation period prior to the 12-week double-blind treatment phase.6
§Limitation: These analyses were not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.

ACUTE STUDY

Nurtec ODT (rimegepant) 75 mg was evaluated in a multi‑center, double‑blind, placebo‑controlled, randomized study to treat a migraine of moderate‑to‑severe pain intensity. A tablet form was also assessed in 2 similarly designed studies, and bioequivalence has been established.1,2

Nurtec® ODT acute study design, see Safety Info

Co‑primary endpoints at 2 hours post-dose:

  • Freedom from pain: defined as a reduction in headache severity from moderate/severe at baseline to no pain1
  • Freedom from most bothersome symptom (MBS): defined as absence of the most bothersome migraine‑associated symptom (photophobia, phonophobia, or nausea)1

Select secondary endpoints at various time points:
Pain relief‡; return to normal function; freedom from MBS and pain; no rescue medication use§; sustained freedom from pain; sustained pain relief; sustained return to normal function1,2,¶

*Patients with stable cardiovascular (CV) disease and CV risk factors were permitted. Stable CV disease was defined as no events within the last 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), uncontrolled hypertension (1 placebo subject).8,9

†Patients were required to wait until their migraine was of moderate-to-severe intensity before treating with the study medication.1

‡Pain relief: defined as the reduction in headache pain from moderate/severe (2 or 3) at baseline to mild/no pain (1 or 0).1,2

§Rescue medication: NSAIDs, acetaminophen and/or antiemetic.1

Return to normal function: defined as the reduction from mild/severe impairment or required bedrest (1, 2, or 3) at baseline to normal functioning (0).1,2

References: 1. Nurtec ODT. Package insert. Pfizer Inc.  2. 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. doi:10.1016 /S0140‑6736(19)31606‑X 3. 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. 2020;397(10268): 51‑60. doi:10.1016/S0140‑6736(20)32544‑7  4. Lipton RB, Coric V, Stock EG, et al. Efficacy, safety, and tolerability of rimegepant 75 mg orally dissolving tablet for the acute treatment of migraine: a phase 3, double‑blind, randomized, placebo‑controlled trial (study 303). Abstract presented at: 61st Annual Scientific Meeting of the American Headache Society; Philadelphia, PA. Session IOR05; July 11, 2019.  5. Data on File. RIM108. Pfizer Inc. 6. 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. Oral Presentation presented at: American Headache Society 2021 Annual Meeting; Nov 18-21.  7. Data on File. RIM159. Pfizer Inc. 8. Data on File. RIM130. Pfizer Inc. 9. Supplement to: 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; published online July 13. http://dx.doi.org/10.1016/ S0140-6736(19)31606-X 10. 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. 2020; published online Dec 15. 11. Data on File. RIM103. Pfizer Inc. 12. Data on File. RIM105. Pfizer Inc. 13. Data on File. RIM106. Pfizer Inc. 14. Data on File. RIM118. Pfizer Inc.

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