Meloxicam and rizatriptan (Symbravo, formerly AXS-07) is a CGRP medication approved for the acute treatment of migraine with or without aura.
Results from the EMERGE phase 3 (NCT05550207) trial achieved the primary end point of demonstrating statistically significant greater migraine treatment response with meloxicam and rizatriptan (Symbravo) compared with oral calcitonin gene-related peptide (CGRP) inhibitors. Meloxicam and rizatriptan is a CGRP medication approved for the acute treatment of migraine with or without aura.1
The EMERGE trial was a phase 3 multicenter, open-label trial that evaluated the efficacy and safety of meloxicam and rizatriptan. | Image Credit: Andrey Popov | stock.adobe.com
“The results of the EMERGE study demonstrate significant improvements in migraine treatment response with Symbravo for patients previously experiencing inadequate response to oral CGRPs based on the mTOQ-4,” Richard B. Lipton, MD, professor of neurology and director of the Montefiore Headache Center at the Albert Einstein College of Medicine, said in a news release.1 “Migraine is a disabling neurological condition, and the multiple mechanisms of action of Symbravo may be relevant to the complex and heterogenous nature of this serious condition. These data from the EMERGE study are compelling and provide further evidence for the utility of Symbravo across a variety of migraine settings.”
Trial Name: Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)
ClinicalTrials.gov ID: NCT05550207
Sponsor: Axsome Therapeutics Inc
Completion Date: November 2024
The EMERGE trial was a phase 3 multicenter, open-label trial that evaluated the efficacy and safety of meloxicam and rizatriptan for the acute treatment of migraine in adults who have a prior inadequate response to an oral CGRP inhibitor, according to the study authors. Previously, the drug demonstrated efficacy in the MOMENTUM (NCT03896009) and INTERCEPT (NCT04163185) trials.2
Investigators included patients with a history of migraine attacks and a prior inadequate response to oral CGRP inhibitors, which was defined by the Migraine Treatment Optimization Questionnaire (mTOQ-4). mTOQ-4 is a questionnaire that assesses treatment efficacy. Patients were treated with the drug for up to 8 weeks or up to 4 migraine attacks. Individuals were at least 18 years of age with a migraine diagnosis, either with or without aura, and experienced 2 to 8 migraine attacks per month.
The co-primary end points included the percentage of individuals with headache pain relief at hour 2 and absence of the most bothersome symptom at hour 2 without the use of rescue medication.2
Investigators found that a significantly greater proportion of patients achieved clinical responses of 2-hour pain freedom, sustained pain freedom, ability to return to normal activities, and ability to plan daily activities. Specifically, pain freedom within 2 hours for most attacks was reported by 47.9% of those receiving meloxicam and rizatriptan, compared with 1% of patients on oral CGRPs. Sustained relief from pain for at least 24 hours after a single dose was reported by 47.9% and 16.7%, respectively. Ability to return to normal activities was reported by 51% and 11.5%, respectively, and ability to plan daily activities was 63.5% and 26%, respectively.1
The drug was well tolerated with a safety profile that was consistent with what was previously reported, with common adverse events being fatigue, nausea, vomiting, muscle tightness, and dizziness.1
The FDA previously approved this treatment in January 2025. The approval was based on positive data from the MOMENTUM and INTERCEPT trials, and the drug is expected to be commercially available in the United States in a few months.3
READ MORE: Headache and Migraine Resource Center
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