Headache Disorders
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Stewart Tepper, AAN 2023: Combination of rizatriptan and AXS-07 – results from the MOMENTUM and INTERCEPT studies

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Published Online: May 26th 2023

A better understanding of the key areas of unmet need regarding acute migraine therapy may help inform drug development and treatment selection. Prof Stewart Tepper (Geisal School of Medicine – Dartmouth, Hanover, NH, USA) summarizes a poster on data from the MOMENTUM trial, a pivotal trial in the treatment of migraine assessing the efficacy and safety of AXS-07 (MoSEIC™ meloxicam and rizatriptan), meloxicam alone, rizatriptan alone, and placebo in a 4-arm acute migraine treatment trial. He also discusses the INTERCEPT study, evaluating the efficacy and safety of AXS-07 in the early acute treatment of migraine.

Disclosures: Stewart Tepper has received grants for research (no personal compensation) from Allergan/Abbvie, Amgen, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma and Zosano. He is a consultant and/or member of the advisory boards (honoraria) for Aeon, Allergan/Abbvie, Alphasights, Amgen, Aruene, Atheneum, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, ClickTherapeutics, CoolTech, CRG, Decision Resources, Defined Health, DRG, Eli Lilly, ExpertConnect, FCB Health, Fenix, GLG, Guidepoint Global, Health Advances, Health Science Communications, HMP Communications, Impel, Initiatior Pharma, InteractiveForums, Keyquest, Ki Health Partners, Krog and Partners, Lundbeck, M3 Global Research, Magnolia Innovation, MJH Holdings, Miravo Healthcare, Neurofront Therapeutics, Neurolief, Novartis, P Value Communications, Pain Insights, Inc,  Palion Medical, Pulmatrix, Putnam Associates, Rehaler, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Strategy Inc, Synapse Medical Communication, System Analytic, Taylor and Francis, Tegus, Teva, Theranica, Tremeau, Trinity Partners, Unity HA, Vial, XOC and Zosano. He receives his salary from Dartmouth-Hitchcock Medical Center and Thomas Jefferson University. He has received CME honoraria from the American Academy of Neurology, American Headache Society, Annenberg Center for Health Sciences, Catamount Medical Education, Diamond Headache Clinic, Forefront Collaborative, Haymarket Medical Education, HMP Global, Medical Education Speakers Network, Medical Learning Institute Peerview, Migraine Association of Ireland, Miller Medical Education, National Association for Continuing Education, North American Center for CME, The Ohio State University, Physicians’ Education Resource, PlatformQ Education, Primed, Vindico Medical Education and WebMD/Medscape.

Support: Interview and filming supported by Touch Medical Media. Interview conducted by Sophie Nickelson.

Filmed as a highlight of the 75thAAN Annual Meeting, 2023

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Hello, I’m Stewart Tepper. I’m a professor of neurology at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire. A combination product was presented at the American Academy of Neurology Meeting for acute treatment of migraine.

This was a combination of Mosaic Meloxicam and Rizatriptan in the same tablet.

This combination has been studied in two pivotal trials, but as of April 2023 had not yet been submitted to the FDA for acute treatment of migraine indication.

The two trials were the momentum trial and the intercept trial.

The momentum trial was a pivotal trial in the treatment of moderate to severe migraine pain, pretty typical for a pivotal acute migraine medication trial, except that in the momentum trial, people were enrolled who had had a previous lack of success with acute medications, making them a bit more challenging to treat.

The intercept trial was a trial in which patients were given the Mosaic Meloxicam Rizatriptan combination and instructed to treat early in the migraine when they were pretty sure migraine was coming, but at mild pain. Again, you can see where this is going through the AAN meeting where treating earlier and earlier in migraine attacks is becoming the standard of care for us providing advice to patients – in this pivotal trial patients treated at mild pain.

During the AAN meeting, a poster was presented on the efficacy of this combination, which is called AXS007, with patients with risk factors for inadequate response to acute migraine trials.

And this was pooled analysis of two hour pain free responses compared to placebo in patients with the following risk factors for an inadequate acute response.

Higher BMI, Allodynia, Morning migraine that is the presence of central sensitization, patient awaking with a full blown migraine, and history of depression.

The pooled two hour pain free responses were 19.1% for the AXS007, versus 9.9% for placebo, for the high BMI 23.1% for AXS007, for the presence of Aladinia, 23.5% for morning migraine, and 23.1% for history of depression, all of them statistically significant over placebo, and all of them, about the same as lower as slower onset triptans or as G pants.

The most common adverse events in the AXS007 group were nausea, at 2.4%, somnolens at 2.1%, dizziness at 1.9% and this is further evidenced that this combination works in people who have the risk factors for poor treatment for acute treatment of migraine, or who have actually as in the momentum study had a previous lack of success with conventional acute medications.

We look forward to the opportunity to try this combination for our patients as the mosaic meloxicam is unique formulation to try to get the meloxicam in more rapidly, and this should work very well in combination with Rizatriptan.

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