Symbravo (AXS-07) for Treatment of Acute Migraine in Adults: Phase 3 Trial Primer

The FDA approved Symbravo, previously AXS-07, for treatment of acute migraine, with or without aura, in adults on January 30, 2025. The novel oral multimechanistic medication combines the rapidly absorbed COX-2 preferential NSAID meloxicam and the 5-HT1 receptor agonist rizatriptan, the latter considered one of the acute migraine therapies with the fastest onset of action. A proprietary technology developed by Symbravo sponsor Axsome Therapeutics, supports the rapid absorption of the NSAID component and sustains plasma half-life.¹

The NSAID/triptan combination is thought to act by inhibiting calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation, and inhibiting neuroinflammation, pain signal transmission, and central sensitization.¹

The FDA based its decision to approve Symbravo on positive findings from pivotal phase 3 clinical trials across migraine scenarios and patient types, including at the earliest sign of migraine pain to prevent headache progression (INTERCEPT) and in adults with moderate to severe migraine pain who had a history of poor response to previous acute treatments (MOMENTUM).

The short slide show above provides an at-a-glance summary of findings from the 2 studies.

1. Axsome Therapeutics announces FDA approval of SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. News release. January 30, 2025. Accessed January 30, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam.