Rimegepant 75 mg Provides Early and Sustained Relief of Migraine with a Single Oral Dose: Results from 3 Phase 3 Clinical Trials

Jelena Pavlovic, MD, PhD

AHSAM 2020 - Oral session
Published on September 11, 2020

3 minute listen

7 minute read

Key messages

  • Patients seek acute treatments that provide rapid and sustained relief of migraine symptoms.
  • Acute treatment with rimegepant 75 mg provides rapid and sustained pain relief for patients experiencing a migraine attack.
  • Background

    What do we already know about this topic?
  • Findings

    What does this study add?
  • Perspectives

    How does this study impact clinical practice?
  • Expert commentary

    by Stephanie J. Nahas, MD, MSEd, FAHS, FAAN

Key messages

  • Patients seek acute treatments that provide rapid and sustained relief of migraine symptoms.
  • Acute treatment with rimegepant 75 mg provides rapid and sustained pain relief for patients experiencing a migraine attack.

Background

What do we already know about this topic?

  • Patients often complain that current acute treatments for migraine take too long to provide pain relief, and relief isn’t lasting.
  • Rimegepant is an orally-administered small molecule calcitonin gene-related peptide (CGRP) receptor antagonist that was recently approved by the FDA having demonstrated efficacy and safety in Phase 3 studies for the acute treatment of migraine.1,2
  • Rimegepant 75 mg orally dissolving tablet (ODT) has a Tmax of 1.5 hours that may translate into early onset of action and a half-life of 10–12 hours, meaning it may provide a sustained effect in acute treatment.

How was this study conducted?

  • Three Phase three, double-blind, randomized, placebo-controlled, multicenter trials of identical design were conducted in adults with a history of episodic migraine (N=3507).
  • Subjects were randomized to receive rimegepant 75 mg tablet or 75 mg ODT (n=1749), or placebo (n=1758), and instructed to treat one migraine attack of moderate-to-severe pain intensity with a single dose of study medication.
  • Coprimary endpoints were freedom from pain and most bothersome symptom (MBS) two hours post-dose.

Findings

What does this study add?

  • Of subjects who received rimegepant 75 mg, 20.1% reported freedom from pain 2 hours post-dose versus 12.2% who received placebo.
  • 36.4% of subjects who took rimegepant 75 mg reported freedom from MBS 2 hours post-dose versus 26.6% who received placebo.
  • Rimegepant 75 mg provided pain relief (defined as pain of mild intensity or none) at 2 hours post-dose for 57.9% of subjects versus 43.9% for placebo, and for up to 48 hours in 37.8% of subjects versus 24.0% on placebo.
  • Sustained normal function from 2 to 48 hours post-dose was reported by 22.3% of subjects on  rimegepant 75 mg versus 13.7% on placebo.
  • Rimegepant 75 mg was well tolerated, with the most common AEs being nausea and UTI.

Perspectives

How does this study impact clinical practice?

  • Acute treatment with Rimegepant 75 mg provides rapid pain relief from migraine for adult patients with a history of migraine.
  • Pain relief is sustained for up to 48 hours with a single dose of rimegepant 75 mg in some patients allowing patients to function normally within that time.

Perspectives

How does this study impact clinical practice?

  • Acute treatment with Rimegepant 75 mg provides rapid pain relief from migraine for adult patients with a history of migraine.
  • Pain relief is sustained for up to 48 hours with a single dose of rimegepant 75 mg in some patients allowing patients to function normally within that time.

This is a highlights summary of an oral session given at the AHSAM 2020 Virtual Annual Scientific Meeting and presented by:

Jelena Pavlovic, MD, PhD
Associate Professor Albert Einstein College of Medicine, Montefiore Headache Center
Bronx, New York

The content is produced by Infomedica, the official reporting partner of ASHAM 2020 Virtual Annual Scientific Meeting. The summary text was drafted by Goldcrest Medical Writing, reviewed by Marco Vercellino, MD, an independent external expert, and approved by Jessica Ailani, MD, FAHS and Mark J. Burish, MD, PhD, the scientific editors of the program.

The presenting authors of the original session had no part in the creation of this conference highlights summary.

In addition, an expert commentary on the topic has been provided by:

Stephanie J. Nahas, MD, MSEd, FAHS, FAAN
Associate Professor of Neurology

Stephanie J. Nahas, MD, MSEd, FAHS, FAAN
Associate Professor of Neurology

Stephanie Nahas achieved her undergraduate degree in biology (cum laude) at Harvard in 1995. She then went to Rush Medical College where, after a brief detour to obtain a Masters degree in instructional technology from the University of Southern California in 1998, she earned her MD in 2001. She completed internship at Rush followed by neurology residency then fellowship in headache medicine at Thomas Jefferson University Hospital. In January 2007, after 1.5 years of fellowship training, she joined faculty and became the Fellowship Program Director at the Headache Center of Thomas Jefferson University. She is a dedicated advocate for the field, having attended 12 Headache on the Hill events in Washington, DC since 2007, and is immediate past Vice President of the Alliance for Headache Disorders Advocacy (February 2018 – February 2020). Dr. Nahas serves as Section Editor for Current Pain and Headache Reports, is Co-Chair of the “First Contacts: Headache Education in Primary Care” Committee of the American Headache Society, and also serves on the Education Committee and Scottsdale Program Committee for the American Headache Society. In August 2020, she was elected as the first President of the Asia Pacific Headache Society.

1. Lipton RB, et al. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. NEJM 2019;381:142-49.

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;394:737-745.



Headache
Headache


Scan to open on your mobile device