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This site is intended for US healthcare professionals only.

Safety

SYMBRAVO was generally well tolerated with a
demonstrated safety profile1

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Most common adverse events

The most common adverse events in controlled trials were somnolence and dizziness.1
Chest tightness was reported in <1% of SYMBRAVO patients.2,3

Incidence of adverse reactions ≥1% and greater than placebo1

The safety profile of SYMBRAVO was
consistent with its active ingredients.1

Long-term safety was consistent with controlled trials1,4,c

The long-term safety of SYMBRAVO was assessed in a 12-month, open-label extension study. Safety outcomes were consistent with those seen in controlled trials.1,4

Enrolled Patients:
Patients who had completed
MOMENTUM or INTERCEPT
Treatment period (up to 12 months)5

SYMBRAVO (20 mg MoSEIC™
meloxicam and 10 mg rizatriptan)

  • Patients experienced at least 2 migraine attacks per month, on average, and were allowed to treat up to 10 migraine attacks per month with 1 dose of SYMBRAVO for each migraine attack5
  • Patients took a dose of SYMBRAVO following the onset of a migraine4
  • Primary endpoint was long-term safety of chronic intermittent use of SYMBRAVO4

Incidence of adverse events occurring in ≥2% of patients in the MOVEMENT open-label extension (OLE) study4

1.8%
1.8% discontinuation rate due to adverse events in the up to 12‑month OLE study with 706 patients in which ~19,000 migraine attacks were treated4,6

SYMBRAVO demonstrated efficacy across migraine attacks in the MOVEMENT study (N=2734 attacks)4

Efficacy was evaluated over the first 4 migraine attacks.4

Percentage of patients with pain relief across the first 4 migraine attacks4,d

97 Percent
97% of patients experienced pain relief during at least 1 out of the first 4 treated attacks4
(in the ITT population of 704 patients)
Chart showing time to pain relief in the MOVEMENT clinical trial Chart showing time to pain relief in the MOVEMENT clinical trial

Percentage of patients with sustained pain relief or pain freedom across first 4 migraine attacks4,e

Rate of sustained pain relief by migraine attack4,f

2-24 hour sustained pain relief
60%
Sustained 2-24 hour pain relief was achieved across 60% of all treated migraine attacks.5
Chart showing rate of sustained pain relief by migraine attack in the MOVEMENT clinical trial Chart showing rate of sustained pain relief by migraine attack in the MOVEMENT clinical trial
The power of a multimechanistic migraine treatment1

Watch a video to learn more about how SYMBRAVO works.

a
Pooled data from INTERCEPT and MOMENTUM studies.1
b
Data from MOMENTUM only. INTERCEPT did not include arms with each individual component.1
c
The MOVEMENT safety population included all patients who received SYMBRAVO.
d
Pain relief was defined as experiencing a moderate (2) or severe (3) headache at baseline, which became mild (1) or none (0); or a mild (1) headache at baseline which became none (0) at the timepoint without taking rescue medication, by 1st, 2nd, 3rd, and 4th migraine episodes.4
e
Sustained headache pain relief was defined as headache pain relief at hour 2, with no use of rescue medication and no worsening of headache pain through 24 and 48 hours.
Sustained headache pain freedom was defined as no headache pain at hour 2, with no use of rescue medication and no relapse of headache pain through 24 and 48 hours.4
f
Sustained headache pain relief was defined as headache pain relief at hour 2, with no use of rescue medication and no worsening of headache pain through 24 hours.4
REFERENCES
  • 1. SYMBRAVO [prescribing information]. New York, NY: Axsome Therapeutics, Inc.
  • 2. Data on file. Axsome Therapeutics, Inc. DOF-SYM-00821.
  • 3. Data on file. Axsome Therapeutics, Inc. DOF-SYM-00795.
  • 4. Data on file. Axsome Therapeutics, Inc. DOF-SYM-02222.
  • 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.
  • 6. Data on file. Axsome Therapeutics, Inc. DOF-SYM-02400.