FDA Approves Axsome’s Symbravo for Acute Migraine Treatment, Overcoming 2022 Rejection
The FDA approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults on January 30, 202523.
This approval comes after an initial rejection in 2022 due to chemistry, manufacturing, and controls (CMC) issues1.
Symbravo is a novel, oral, single-dose medication that combines meloxicam (an NSAID) and rizatriptan (a 5-HT1B/1D agonist)23.
The drug utilizes Axsome's proprietary MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology for rapid absorption36.
Clinical trials demonstrated that Symbravo provides rapid migraine pain relief within 2 hours and sustained efficacy for up to 24-48 hours36.
In Phase 3 studies, 85% and 77% of patients treated with Symbravo did not require rescue medication within 24 hours36.
Symbravo showed efficacy across a broad range of migraine severity (mild, moderate, and severe)36.
The most common adverse reactions were somnolence and dizziness, reported in 2% and 1% of patients, respectively36.
Axsome expects Symbravo to be commercially available in the U.S. in approximately four months23.
The approval of Symbravo represents a new multi-mechanistic approach to treating migraine, targeting multiple pathways underlying a migraine attack34.
Sources:
1. https://www.fiercebiotech.com/biotech/expected-fda-spikes-down-axsome-migraine-med-calls-issues-addressable
2. https://practicalneurology.com/news/the-fda-approved-a-new-oral-as-needed-tablet-for-acute-migraine-treatment
3. https://www.biospace.com/press-releases/axsome-therapeutics-announces-fda-approval-of-symbravo-meloxicam-and-rizatriptan-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults
4. https://www.biospace.com/fda/axsomes-migraine-medicine-clears-fda-bar
6. https://www.globenewswire.com/news-release/2025/01/30/3018389/0/en/Axsome-Therapeutics-Announces-FDA-Approval-of-SYMBRAVO-meloxicam-and-rizatriptan-for-the-Acute-Treatment-of-Migraine-with-or-without-Aura-in-Adults.html