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

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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

Chart with INTERCEPT coprimary endpoints. Chart with INTERCEPT coprimary endpoints. Chart with MOMENTUM coprimary endpoints. Chart with MOMENTUM coprimary endpoints.

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.