Efficacy

Actual Nurtec ODT Patient

One dose.
Rapid and sustained results.1

brain with migraine attack

Freedom from pain
and MBS*

on the go running errands

Return to
normal function

Pain
relief

See below for data across these efficacy measures at various timepoints.

*Co-primary endpoints at 2 hours.

Select secondary endpoints at various timepoints.

Study Design

Nurtec ODT 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

Screening Phase2

People with stable cardiovascular (CV) disease and CV risk factors were permitted3,*


Treatment Phase2

Up to 45 days

1:1 Randomization
(N=1351)1,2

Patients were given one dose to take during an attack of moderate to severe pain intensity.1,†

Nurtec ODT 75 mg
(n=669)1

Placebo
(n=682)1

Rescue medication permitted 2 hours after treament1

Co‑primary endpoints at 2 h post dose:

  • Freedom from pain: defined as a reduction in headache severity from moderate/severe at baseline to no pain.1
  • 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; freedom from functional disability, MBS, pain; no rescue medication use§; and sustained freedom from pain, pain relief, and freedom from functional disability.1,2,‖

*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).3

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).3

View full study design

Back to normal function
in just one dose1-3

Rapid Response1-3

Freedom from functional disability

9%*
n=63

7%
n=45

22%
n=149

16%
n=108

38%
n=255

26%
n=176

54%*
n=359

32%
n=216

Nurtec ODT 75 mg (N=669)

Placebo (N=682)

p=0.0025

p<0.001

*exploratory analysis

Sustained Response1-3

From 2-48 hours

48h

68% of patients taking Nurtec ODT with normal functioning at 2 hours had a sustained response through 48 hours

68% (n=174/255) of patients taking Nurtec ODT vs 60% (n=105/176)
of patients taking placebo

26% of patients taking Nurtec ODT 75 mg (n=174/669) experienced freedom from functional disability from 2-48 hours vs 15% of patients taking placebo (n=105/682); p<0.0001

Superiority over placebo within
2 hours and beyond1-3

Co-primary endpoints
at 2 hours1

Secondary endpoint
at 2 hours1-3

21%*
n=142

11%
n=74

35%
n=235

27%
n=183

59%*
n=397

43%
n=295

Nurtec ODT 75 mg (N=669)

Placebo (N=682)

*p<0.001

p=0.001

MBS: most bothersome symptom (photophobia, phonophobia, or nausea)2

Nearly
60%
of patients
achieved pain relief
at 2 hours


Rapid Response1-3

Freedom from pain

15%*
n=101

7%
n=50

21%
n=142

11%
n=74

39%
n=258

20%
n=137

49%
n=331

26%
n=179

Nurtec ODT 75 mg (N=669)

Placebo (N=682)

*p<0.0001

p<0.001

exploratory analysis

Sustained Response1-3

From 2-48 hours

48h

63% of patients taking Nurtec ODT who experienced freedom from pain at 2 hours maintained it through 48 hours

63% (n=90/142) of patients taking Nurtec ODT vs 50% (n=37/74) of patients taking placebo

14% of patients taking Nurtec ODT 75 mg (n=90/669) experienced freedom from pain from 2-48 h vs 5% of patients taking placebo (n=37/682); p<0.001

Up to 48 hours
of pain relief in
one dose1-3

Rapid Response1-3

Pain Relief

8%*
n=52

5%
n=36

37%
n=246

31%
n=213

59%
n=397

43%
n=295

71%*
n=476

50%
n=338

Nurtec ODT 75 mg (N=669)

Placebo (N=682)

p<0.05

p<0.001

*exploratory analysis

Sustained Response1-3

From 2-48 hours

48h

71% of patients taking Nurtec ODT
who achieved pain relief at 2 hours
experienced sustained pain relief
through 48 hours

71% (n=282/397) of patients taking
Nurtec ODT vs 58% (n=172/295)
of patients taking placebo

42% of patients taking Nurtec ODT 75 mg (n=282/669) experienced pain relief from 2-48 hours vs 25% of patients taking placebo (n=172/682); p<0.0001

Lasting migraine relief
in just
one dose1-3

Minimal need for
rescue medication1

Actor Portrayal

86% of patients did not take a rescue medication (including OTCs) within 24 hours post dose1

Study Design

Nurtec ODT 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

Screening Phase2

People with stable cardiovascular (CV) disease and CV risk factors were permitted3,*


Treatment Phase2

Up to 45 days

1:1 Randomization
(N=1351)1,2

Patients were given one dose to take during an attack of moderate to severe pain intensity.1,†

Nurtec ODT 75 mg
(n=669)1

Placebo
(n=682)1

Rescue medication permitted 2 hours after treament1

Co‑primary endpoints at 2 h post dose:

  • Freedom from pain: defined as a reduction in headache severity from moderate/severe at baseline to no pain.1
  • 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; freedom from functional disability, MBS, pain; no rescue medication use§; and sustained freedom from pain, pain relief, and freedom from functional disability.1,2,‖

*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).3

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).3

Select endpoints were recorded using the scales that follow*:

Migraine pain score2,3,†,‡
migraine pain score

Freedom from pain was defined as none (0) at the designated time points. Pain relief was defined as shift from moderate (2) or severe (3) intensity to mild (1) or none (0).2,3


Most bothersome symptom2,3,§
Nausea, phonophobia, photophonia

Patients with moderate to severe migraine selected most bothersome symptom (MBS). Severity of MBS was scored using the same scale as pain.1,3

*Patients recorded their scores using an electronic diary (eDiary).3

Freedom from pain: defined as a reduction in headache severity from moderate/severe at baseline to no pain.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

§Freedom from MBS: defined as absence of the most bothersome migraine-associated symptom (photophobia, phonophobia, or nausea).1

References: 1. Nurtec ODT [prescribing information]. New Haven, CT: Biohaven Pharmaceuticals, Inc. 2. Croop R 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. 3. Data on File 001. Biohaven Pharmaceuticals, Inc.

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Safety

Important Safety Information

Contraindications: Hypersensitivity to Nurtec ODT or any of its components.

Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received Nurtec ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with Nurtec ODT.

Drug Interactions: Avoid concomitant administration of Nurtec ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P‑gp or BCRP. Avoid another dose of Nurtec ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Use in Specific Populations: Pregnant/breast feeding: It is not known if Nurtec ODT can harm an unborn baby or if it passes into breast milk. Hepatic impairment: Avoid use of Nurtec ODT in persons with severe hepatic impairment. Renal impairment: Avoid use in patients with end-stage renal disease.

Indication

Nurtec ODT is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use
Nurtec ODT is not indicated for the preventive treatment of migraine.

Please click here for full Prescribing Information.