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efficacy

Allie S
Actual Nurtec ODT Patient

*Per IQVIA as oral brand in class (oral CGRP receptor antagonists): number one prescribed,
number one in new prescriptions, and more neurologists selected as brand of choice

The only migraine medication that can Treat & Prevent all in one1,2

Treating migraine attacks when they happen

Proven freedom from pain and MBS at 2 hours (PRN dosing) for many patients1

Preventing the next one from happening

Proven reduction in monthly migraine days 9‑12 weeks (EOD dosing) for many patients1

I love that Nurtec ODT can get rid of my migraine pain fast! Nurtec ODT can treat or prevent my migraines, so I feel better about making plans.

Kris W

Actual Nurtec ODT patient 
Individual results may vary

My migraines are triggered by the heat, so going into the summer and finding out that the medication I trust to stop migraine attacks is proven to prevent migraines too? It's some of the best news I've gotten all year. Thank you Nurtec ODT, you guys are awesome!

Brittany W

Actual Nurtec ODT patient 
Individual results may vary

Study designs

For the acute indication, Nurtec ODT was evaluated in a multi‑center, double‑blind, randomized, placebo‑controlled study of 1351 patients (Nurtec ODT 75 mg, n=669; placebo, n=682), with co‑primary endpoints at 2 h for Nurtec ODT vs placebo: pain freedom (21% vs 11%, P<.001) and freedom from most bothersome symptoms (MBS; predefined as photophobia, phonophobia, or nausea; 35% vs 27%; P=.001).1

For the preventive indication, rimegepant 75 mg was evaluated in a multi‑center, double‑blind, randomized, placebo‑controlled study of 695 patients (rimegepant 75 mg, n=348; placebo, n=347) with the primary endpoint being change from baseline in the mean number of monthly migraine days during weeks 9‑12 (-4.3 vs -3.5, P=.01).1

A long-term open label safety study with 1800 patients evaluated rimegepant 75 mg dosed as needed for 52 weeks (N=1514) and dosed every other day plus as needed for 12 weeks (N=286).1,3

FAST:

Rapid onset can get many patients back to normal activities and reduce migraine frequency1,4,5

Treating migraine attacks

Starts working in minutes to eliminate pain and get many patients back to normal activities in 1 hour1,4-6

Nurtec ODT has a half-life of 11 hours1

  • The elimination half-life was analyzed in healthy subjects

Rapid Response1,4,5,7

Back to Normal Activities

Rapid response - pain relief of Nurtec ODT vs Placebo

Back to normal activities = return to normal function

Preventing the next one

Provided a 30% reduction in weekly 
migraine days at Week 1 for many patients8,§

Reduction in Weekly Migraine Days During Week 18,§

§Exploratory analysis. Subjects had ≥1 day of efficacy data in the observation period and in the first week of the double-blind treatment period.8 Secondary endpoints included change in mean number of total migraine days per month during weeks 1‑4 (-2.9 vs -1.7, P<.0001).2

Nominal P value in hierarchical testing.

LASTS:

Sustained efficacy for lasting migraine control for many patients1,4,5,9

Treating Migraine Attacks

Can keep patients functioning and free from migraine pain for up to 2 days—without rescue medication1,5

Sustained Response1

From 2-48 hours

48h

  • 63% of patients taking Nurtec ODT (n=90/142) who experienced freedom from pain at 2 hours maintained it through 48 hours vs 50% (n=37/74) of patients taking placebo1
  • 14% of patients taking Nurtec ODT 75 mg (n=90/669) experienced freedom from pain from 2-48 hours vs 5% of patients taking placebo (n=37/682); P<.0011

86% of patients did not take a rescue medication (including OTCs) within 24 hours post dose.1

Preventing the next one

Reduction in monthly migraine days month over month

REDUCTION IN MONTHLY
MIGRAINE DAYS (MMDs) at month 31

49%
of patients

Approximately half (n=171/348) of patients taking rimegepant decreased their moderate to severe MMDs by ≥50% versus 41% (n=144/347) of those taking placebo; P=.0441,2,*

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

*Baseline MMDs during the 4-week observation period was 10.3 for rimegepant-treated subjects and 9.9 for placebo-treated subjects.2

The best part is how quickly it can work.

Melissa J

Actual Nurtec ODT patient
Individual results may vary

I swear Nurtec ODT is the best thing ever for me! I get really bad migraines that keep me in bed for days. Now that I've been taking Nurtec ODT, I have my life back! 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

CO-PRIMARY ENDPOINTS

Superiority over Placebo at 2 hours post dose1

NURTEC ODT WAS SUPERIOR TO PLACEBO1

Graph of co-primary and secondary endpoints for Nurtec ODT vs placebo

Patients using rescue medications at or before the assessment and patients not providing data were classified as treatment failures.4

Patients treated with rimegepant demonstrated a significant reduction in mean MMDs with EOD dosing1

Reduction of MMDs during
weeks 9 to 121

EOD=every other day; MMD=monthly migraine days

Patients treated with rimegepant demonstrated a 4.3-day reduction from baseline in MMDs during weeks 9 to 12, versus a 3.5-day reduction for placebo.1

Baseline MMDs during the 4-week observation period was 10.3 for rimegepant-treated subjects and 9.9 for placebo-treated subjects.2

Acute Study

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.1,4

SCREENING PHASE4,10

Patients with stable cardiovascular (CV) disease and CV risk factors were permitted*


TREATMENT PHASE1,4

Up to 45 days

1:1 Randomization
(N=1351)

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

Nurtec ODT 75 mg
(n=669)

Placebo
(n=682)

Rescue medication permitted 2 hours after treatment

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; back to normal activities, freedom from MBS and pain; no rescue medication use§; and sustained freedom from pain, pain relief, and return to normal function.1,4,‖

Back to normal activities = return to normal function

*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).10,11

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).1,4

§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).1,4

Preventive Study

Rimegepant 75 mg was evaluated for the preventive treatment of migraine in a multi-center, double-blind, placebo-controlled, randomized clinical trial.1

Study design of Nurtec preventive study

Primary endpoint:

  • Change from baseline in the mean number of monthly migraine days (MMDs) during weeks 9 through 12 of the double-blind treatment phase.1

Secondary endpoint:

  • Percentage of patients who achieved a ≥50% reduction in moderate to severe MMDs during weeks 9‑121

References: 1. Nurtec ODT. Package insert. Biohaven Pharmaceuticals Inc. 2. 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. 3. McGinley JS, L'Italien GJ, Thiry AC, et al. Rimegepant 75 mg results in reductions in monthly migraine days: Secondary analysis of a multicenter, open label, long‑term safety study of rimegepant for the acute treatment of migraine. Virtual Poster presented at: American Academy of Neurology 2020 Annual Meeting; 2020. 4. 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. 5. 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. 6. Data on File. RIM108. Biohaven Pharmaceuticals Inc. 7. Data on File. RIM106. Biohaven Pharmaceuticals Inc. 8. Lipton RB, Croop R, Jensen CM, et al. Rapid Decrease in Migraine Days With Rimegepant: Results From a Post Hoc Analysis of a Phase 2/3, Randomized, Double‑Blind, Placebo‑Controlled Trial. Virtual Poster presented at: American Headache Society 2021 Annual Meeting; June 3-6, 2021. 9. Data on File. RIM103. Biohaven Pharmaceuticals Inc. 10. Data on File. RIM130. Biohaven Pharmaceuticals Inc. 11. 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. http://dx.doi.org/10.1016/S0140-6736(20)32544-7. 12. Data on File. RIM118. Biohaven Pharmaceuticals Inc. 13. Data on File. RIM105. Biohaven Pharmaceuticals Inc.