Symbravo FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 2, 2025.
FDA Approved: Yes (First approved January 30, 2025)
Brand name: Symbravo
Generic name: meloxicam and rizatriptan
Dosage form: Tablets
Previous Name: AXS-07
Company: Axsome Therapeutics, Inc.
Treatment for: Migraine
Symbravo (meloxicam and rizatriptan) is a non-steroidal anti-inflammatory drug and triptan combination indicated for the acute treatment of migraine with or without aura in adults.
- Migraine is a type of headache characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea and vomiting, and sensitivity to light and sound.
- Symbravo is a combination treatment containing meloxicam, a selective COX-2 inhibitor non-steroidal anti-inflammatory drug first approved under the brand name Mobic for the treatment of osteoarthritis in 2000, and rizatriptan, a 5-HT1B/1D agonist first approved for the acute treatment of migraine under the brand name Maxalt in 1998. Meloxicam for the treatment of migraine is enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of the drug while maintaining a long plasma half-life.
- Symbravo utilizes the analgesic, anti-inflammatory, and antipyretic properties of meloxicam and the vasoconstrictor effects of rizatriptan to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of Symbravo in the treatment of acute migraine is unknown.
- FDA approval of Symbravo was based on the results of the Phase 3 MOMENTUM trial (that treated migraine of moderate and severe pain intensity), the Phase 3 INTERCEPT trial (that treated migraine when the initial pain was mild), and the Phase 3 MOVEMENT long-term open label safety trial.
- In the MOMENTUM and INTERCEPT trials, a single dose of Symbravo demonstrated a statistically significantly greater percentage of patients achieving rapid migraine pain freedom and return to normal functioning at 2 hours compared to placebo, and sustained efficacy through 24 and 48 hours. Rescue medication was not required within 24 hours post dose in 77% of patients in the MOMENTUM trial and 85% of patients in the INTERCEPT trial. - Symbravo is administered orally as needed. The maximum daily dose is one tablet (meloxicam 20 mg and rizatriptan 10 mg).
- Symbravo comes with a Boxed Warning for the increased risk of serious cardiovascular thrombotic events and serious gastrointestinal adverse events.
- Common adverse reactions (≥1% and greater than placebo) include dizziness and somnolence.
Development timeline for Symbravo
Further information
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