Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam/Rizatriptan) in the Acute Treatment of Migraine: Results from the MOMENTUM Phase 3 Trial

Cedric O'Gorman, MD

AHSAM 2020 - Oral session
Published on September 11, 2020

7 minute
3 minute

This Medfyle was published more than two years ago. More recent Medfyle on this topic may now be available.

Key messages

  • Over 70% of patients are not fully satisfied with their current treatments, mainly due to suboptimal efficacy, and 80% would try a new therapy.
  • Ineffective acute treatment may contribute to medication overuse, chronification of migraine and poor long-term outcomes.
  • AXS-07 treatment resulted in rapid, sustained, substantial and statistically significant efficacy compared to rizatriptan, meloxicam and placebo.
  • AXS-07 provided significant benefit to patients with acute migraine and a history of inadequate response to prior treatments, even in patients with difficult-to-treat migraines.
  • 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 Randolph W. Evans, MD

Key messages

  • Over 70% of patients are not fully satisfied with their current treatments, mainly due to suboptimal efficacy, and 80% would try a new therapy.
  • Ineffective acute treatment may contribute to medication overuse, chronification of migraine and poor long-term outcomes.
  • AXS-07 treatment resulted in rapid, sustained, substantial and statistically significant efficacy compared to rizatriptan, meloxicam and placebo.
  • AXS-07 provided significant benefit to patients with acute migraine and a history of inadequate response to prior treatments, even in patients with difficult-to-treat migraines.

Background

What do we already know about this topic?

  • AXS-07 (MoSEIC™ meloxicam 20 mg/rizatriptan 10 mg) is a novel, oral, multi-mechanistic investigational medicine under development for the acute treatment of migraine.
  • AXS-07 inhibits calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain signal transmission and central sensitization. 1,2,3,4

How was this study conducted?

  • MOMENTUM was a Phase 3 randomized, double-blind, placebo- and active-controlled multicenter study on adult patients with an inadequate response to prior acute migraine treatments (N=1,594).
  • Patients were randomized in a 2:2:2:1 ratio to AXS-07 (MoSEIC™ meloxicam 20 mg/rizatriptan 10 mg), rizatriptan 10 mg, MoSEIC™ meloxicam 20 mg, or placebo, to treat a single (moderate or severe) migraine attack.
  • Co-primary endpoints were pain freedom and freedom from most bothersome symptom (MBS) 2 hours after dosing for AXS-07 compared to placebo
  • Secondary endpoint was sustained pain freedom from 2–24 hours after dosing.

Findings

What does this study add?

  • Compared with placebo, a statistically significant greater proportion of patients were pain free and free of MBS at 2 hours with AXS-07 treatment.
  • A statistically significant greater percentage of AXS-07 patients achieved sustained pain freedom from 2–24 hours after dosing compared to rizatriptan and MoSEIC™ meloxicam.
  • Efficacy benefits of AXS-07 translated into statistically significantly better patient global assessment of response, return to normal functioning and reduced rescue medication use.
  • AXS-07 was well tolerated, with the most common adverse events being nausea, dizziness and somnolence, none of which occurred at a higher rate than placebo.

Perspectives

How does this study impact clinical practice?

  • There is a need to better understand unmet treatment needs and predictors of poor response to acute migraine treatments.
  • The multi-mechanistic approach of AXS-07 may represent a superior treatment choice for patients, especially those with more difficult-to-treat migraine.

Perspectives

How does this study impact clinical practice?

  • There is a need to better understand unmet treatment needs and predictors of poor response to acute migraine treatments.
  • The multi-mechanistic approach of AXS-07 may represent a superior treatment choice for patients, especially those with more difficult-to-treat migraine.

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

Cedric O'Gorman, MD
Senior Vice President, Clinical Development and Medical Affairs
Axsome Therapeutics Inc.
New York, 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:

Randolph W. Evans, MD
Baylor College of Medicine

Randolph W. Evans, MD
Baylor College of Medicine

Randolph W. Evans, MD received his B.A. from Rice University in 1974 and M.D. from Baylor College of Medicine in 1978. Dr. Evans completed his internship and residency in Neurology at Baylor College of Medicine in 1982. He is board certified in Neurology and subspecialty certified in Headache Medicine and a fellow of the American Academy of Neurology, the American Headache Society, and the Texas Neurological Society.

 Dr. Evans is clinical professor at Baylor College of Medicine and on the staff of HCA Houston Healthcare Medical Center, the Houston Methodist Hospital, and CHI Baylor St. Luke’s Medical Center Hospital.

Dr. Evans has numerous publications. Books include the following: senior editor of Prognosis of Neurological Disorders, 1st and 2nd editions and editor of Neurology and Trauma, 1st and 2nd editions;  Iatrogenic Disorders;  Diagnostic Testing in Neurology;  Neurologic Treatment;  the Saunders Manual of Neurologic Practice;  Case Studies in Neurology ;  Secondary Headache Disorders 1st and 2nd editions;  Neurology Case Studies;  Common Neurologic Disorders;  Migraine and other Primary Headaches 1st and 2nd editions; the co-author of Handbook of Headache, 1st and 2nd editions; and the co-author of Modern Day Management of Headache.  Dr. Evans is an author of over 325 journal publications and 85 book chapters and is on the editorial boards of many publications including Headache, Medlink Neurology, Headache Currents, Practical Neurology, Medscape Neurology and Neurosurgery, Neurology and Therapy, and consulting editor of Neurologic Clinics of North America.  Dr. Evans has been an ad hoc peer reviewer for numerous additional journals including BMJ, Lancet, Lancet Neurology, Neurology, and the New England Journal of Medicine and a subject advisor for BMJ.

Media appearances include ABC-News, CNN-Headline News, Univision, CBS radio, The Learning Channel, BBC radio, the Houston Chronicle, the New York Times, the LA Times, Wall Street Journal, USA Today, todaynbc.com, foxnews.com, and msnbc.com. Dr. Evans has been listed in the publications “Best Doctors in America,” America’s Top Doctors,”  “Guide to America’s Top Physicians,” “US News Top Doctors,” “Texas Super Doctors,” “Top Doctors in Houston,” and “Doctors Choice Award.” Dr. Evans received the 2014 Texas Neurological Society’s Lifetime Achievement Award. Offices held include president of the Harris County Neurological Society (2002-2003), president of the Texas Neurological Society (2005-2006), and chief of neurology at HCA Houston Healthcare Medical Center (1986-2008; 2014-).

1. Geppetti P, Rossi E, Chiarugi A, et al. Antidromic vasodilatation and the migraine mechanism. The Journal of Headache and Pain 2012;13:103-111.

2. Li C, Zhu Q, He Q, et al. Plasma Levels of Cyclooxygenase-2 (COX-2) and Visfatin During Different Stages and Different Subtypes of Migraine Headaches. Medical Science Monitor 2017;23:24-28.

3. Sarchielli P, Alberti A, Codini M, et al. Nitric oxide metabolites, prostaglandins and trigeminal vasoactive peptides in internal jugular vein blood during spontaneous migraine attacks. Cephalalgia 2000;20:907-918. 

4. Burstein R, Cutrer MF, Yarnitsky D. The development of cutaneous allodynia during a migraine attack clinical evidence for the sequential recruitment of spinal and supraspinal nociceptive neurons in migraine. Brain 2000;123:1703-1709.

Headache
Migraine

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