NOW FDA
APPROVED
SYMBRAVO
The power to deliver rapid, lasting migraine relief 1
SYMBRAVO provided rapid freedom from migraine pain and most bothersome symptoma at 2 hours and lasting pain freedom through 24 hours for some patients.
AVAILABLE IN THE COMING MONTHS
For patients who aren't getting the relief they need, discover SYMBRAVO1
SYMBRAVO is a new 1-tablet medication for the acute treatment of migraine with or without aura in adults.1 It offers a new option for migraine sufferers, including those who had inadequate response to prior acute migraine treatments.2
What makes SYMBRAVO different is MoSEIC™ absorption-accelerating technology combined with meloxicam and rizatriptan.1,3 The absorption of both active ingredients was shown to be accelerated in this patented formulation.1,4
The clinical significance of MoSEIC™ pharmacokinetic impact on the active ingredients in SYMBRAVO has not been established; it is not known precisely how MoSEIC™ technology works to accelerate the absorption of rizatriptan.
Across 2 controlled trials,
SYMBRAVO delivered powerful results1:
Rapid freedom from migraine painb and MBS (coprimary endpoints)a
Significantly greater percentage of patients experienced sustained pain freedom vs rizatriptan
In the MOMENTUM trial (N=1594), 16.1% of patients taking SYMBRAVO experienced sustained pain freedom through 24 hours vs 11.2% with rizatriptan (P=0.038, secondary endpoint).1,d,e
Generally well tolerated with an established safety profile
Across 2 controlled trials and a 12-month open-label extension study, SYMBRAVO was generally well tolerated with a safety profile consistent with its individual components.1,5 The most common adverse events in controlled trials were somnolence (2%) and dizziness (2%).1
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- a
- MBS freedom was defined as the absence of the self-identified MBS (ie, photophobia, phonophobia, or nausea).1
- b
- Pain freedom was defined as a reduction to no headache pain.1
- c
- INTERCEPT was a randomized, double-blind, controlled trial in 302 patients with a history of migraine, with or without aura in which patients took a single dose of SYMBRAVO.1 Efficacy analysis was performed on the intent-to-treat (ITT) population, which included all patients who were randomized and had a qualifying migraine event (267 adult patients: SYMBRAVO, N=132; placebo, N=135). P-values were based on chi-squared test. Missing data were not imputed.2
- d
- MOMENTUM was a randomized, double-blind, controlled trial in 1594 patients [SYMBRAVO (N=456), 10-mg rizatriptan (N=456), 20-mg meloxicam (N=455), placebo (N=227)] with a history of migraine with or without aura in which patients took a single dose of SYMBRAVO.1 Efficacy analysis was performed on the intent-to-treat population (1477 adult patients with migraine: SYMBRAVO, N=428; rizatriptan, N=419; meloxicam, N=421; placebo, N=209). P-values were based on chi-squared test. Missing data were not imputed.2
- e
- Patients who did not meet all the following requirements were considered nonresponders: pain intensity at and between hours 2 and 24 was 0; pain intensity was available for at least hour 12 or 16; and no rescue medication was used through hour 24.2
REFERENCES
1. SYMBRAVO [prescribing information]. New York, NY: Axsome Therapeutics, Inc.; 2025. 2. Data on file. Axsome Therapeutics, Inc. 3. Tepper S, Lipton RB, Chhabra A, Streicher C, Parks G, Tabuteau H. Combined efficacy and safety of AXS-07 (MoSEIC™ meloxicam and rizatriptan) in two phase 3 clinical trials. Poster presented at: 76th American Academy of Neurology (AAN) Annual Meeting, April 13–18, 2024. 4. O’Gorman C, Jones A, TenHuisen K, et al. AXS-07 (MoSEIC™ meloxicam/rizatriptan): novel oral therapeutic in clinical development for the acute treatment of migraine. Presented at: 19th International Headache Society Congress, September 5–8, 2019. 5. Jones A, O’Gorman C, Tabuteau H. Treatment of migraine pain and associated symptoms with AXS-07: results from MOVEMENT, a long-term efficacy and safety study. Presented at: 63rd American Headache Society (AHS) Annual Scientific Meeting; June 3–6, 2021.