Medical Insights on the Recent Approval of AXS-07 for Acute Migraine Treatment: Stewart Tepper, MD

WATCH TIME: 4 minutes

“The hope is that as we educate practitioners, the understanding of why combining an [nonsteroidal anti-inflammatory drug] with a triptan should provide additional benefit in the acute treatment of migraine for patients will become more and more clear, and that is my hope for the future."

Migraine is a debilitating neurological disorder marked by recurrent episodes of pulsating head pain, often accompanied by nausea and sensitivity to light and sound. Current acute treatments remain suboptimal, with over 70% of patients expressing dissatisfaction because of slow or inconsistent pain relief and pain recurrence.¹ Studies show poor acute treatment has been linked to an increased risk of chronic migraine, which may be mitigated by improving treatment outcomes. In addition, predictors of poor response have included allodynia, severe migraine pain, obesity, and morning migraines. Thus, there is an urgent need for new acute therapies that offer faster, more consistent, and sustained relief for this serious condition.

AXS-07 (Axsome Therapeutics), a novel combination therapy, aims to address the limitations of current acute migraine treatments by leveraging multiple mechanisms of action. It consists of MoSEIC (Molecular Solubility Enhanced Inclusion Complex) meloxicam, a rapidly absorbed COX-2 preferential nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan, a potent 5-HT1B/1D agonist known for its fast-acting efficacy in migraine relief. The proprietary MoSEIC delivery technology is designed to enhance meloxicam’s solubility and absorption while extending its plasma half-life. By combining these agents, AXS-07 offers a pharmacokinetic profile that may lead to more effective and sustained migraine management.

Earlier this week, the FDA approved AXS-07, marketed as Symbravo, as a new acute treatment for migraine with or without aura in adults, with supportive data from 2 phase 3 randomized controlled clinical trials—the MOMENTUM trial (NCT03896009) and the INTERCEPT trial (NCT04163185).² Following the news, Stewart Tepper, MD, a professor of neurology at the Geisel School of Medicine at Dartmouth and vice president of the New England Institute for Neurology and Headache, shared his reaction in a recent interview with NeurologyLive^®. In the conversation, Tepper discussed the benefits of combining an NSAID with a triptan for acute migraine, highlighting its enhanced efficacy over monotherapy. He also examined trial designs assessing real-world effectiveness of AXS-07 and emphasized the need for better provider education as well as patient access to this treatment.

REFERENCES
1. Smelt AF, Louter MA, Kies DA, et al. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014;9(6):e98933. Published 2014 Jun 16. doi:10.1371/journal.pone.0098933
2. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. News Release. Axsome Therapeutics. Published January 30, 2025. Accessed February 4, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam

Editor’s note: Tepper has received advisory fees from numerous pharmaceutical and healthcare organizations, including AbbVie, Amgen, Axsome Therapeutics, Eli Lilly, Lundbeck, Novartis, Pfizer, Teva, and others. He has received honoraria for lectures and continuing medical education from institutions such as the American Academy of Neurology, the American Headache Society, Medscape, and multiple medical education providers. Additionally, he has received research funding from Aeon, AbbVie, Eli Lilly, Lundbeck, Neurolief, Pfizer, and Suven. Travel support has been provided by AbbVie, the American Headache Society, Diamond Headache Clinic, Eli Lilly, and Pfizer.