Efficacy

The power to deliver rapid, long-lasting migraine pain freedom¹

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SYMBRAVO trials studied efficacy across the headache
phase for mild or moderate to severe migraine pain¹

Earlier in the headache phase when pain was mild

Later in the headache phase when pain was moderate to severe

INTERCEPT TrialRandomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura; single dose of SYMBRAVO taken^1,2

Treated earlier in the headache phase when pain was mild¹

All patients had a diagnosis of migraine with or without aura¹

Later in the headache phase
when pain was moderate to severe

MOMENTUM TrialRandomized, double-blind, placebo-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; single dose of SYMBRAVO taken^1,3

Treated later in the headache phase when pain was moderate to severe¹

All patients had a diagnosis of migraine with or without aura¹
All patients had a history of inadequate response to prior acute migraine medication^3,a

^a: As defined by Migraine Treatment Optimization Questionnaire (mTOQ-4), a questionnaire used to assess treatment efficacy. To be eligible for the MOMENTUM trial, patients needed mTOQ-4 scores of ≤7, indicating inadequate response to their prior migraine therapy over the preceding 4 weeks at screening. The maximum total score is 8, representing maximal treatment efficacy.^3,4

SYMBRAVO was effective earlier in the headache phase when pain was still mild¹

INTERCEPT was a randomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine with or without aura, in which patients took a single dose of SYMBRAVO.¹

INTERCEPT study design^1,a

Chart showing the study design of the INTERCEPT clinical trial

Coprimary endpoints¹

Pain freedom^b at 2 hours^c
Freedom from most bothersome symptom^d at 2 hours^c

Secondary endpoints^1,2

Pain freedom over time
24-hour sustained pain freedom^e
Use of rescue medication from 2 to 24 hours^f

Baseline characteristics across both treatment groups

Demographics¹

~42 yearsmean age

85%female

~29 kg/m²mean BMI

Migraine impact^1,2

24average MIDAS score
(indicates severe disability)

100%experienced mild
migraine pain intensity

28%prior triptan use

Efficacy earlier
in the headache phase¹

See results from the INTERCEPT trial.

^a: INTERCEPT was a randomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura, in which patients took a single dose of SYMBRAVO. 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.^1,2

^b: Pain freedom was defined as a reduction to no headache pain.¹

^c: Patients who took rescue medication before hour 2 or who did not have an hour 2 value were treated as nonresponders.²

^d: MBS freedom was defined as the absence of the self-identified MBS (ie, photophobia, phonophobia, or nausea).¹

^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

^f: Rescue medication was only allowed 2 hours after initial treatment.¹

: BMI, body mass index; MIDAS, Migraine Disability Assessment Score.

Rapid freedom from migraine pain and MBS at 2 hours^1,a,b

SYMBRAVO achieved both coprimary endpoints in a patient population
who took a single dose when pain was still mild in intensity.¹

Pain freedom at 2 hours^1,c

Chart showing pain freedom at 2 hours in the INTERCEPT clinical trial

MBS freedom at 2 hours^1,d

Chart showing MBS freedom at 2 hours in the INTERCEPT clinical trial

More patients taking SYMBRAVO experienced freedom from photophobia (43.2% vs 20.5%) and phonophobia (43.8% vs 25.0%) at 2 hours vs placebo.¹

Long-term results

See data from the MOVEMENT 12-month, open-label extension study.

^a: INTERCEPT was a randomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura, in which patients took a single dose of SYMBRAVO. 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.^1,2

^b: Patients who took rescue medication before hour 2 or who did not have an hour 2 value were treated as nonresponders.²

^c: Pain freedom was defined as a reduction to no headache pain.¹

^d: MBS freedom was defined as the absence of the self-identified MBS (ie, photophobia, phonophobia, or nausea).¹

Pain freedom over time vs placebo^1,2,a

Pain freedom over time (secondary endpoint)^1,2,b

Chart showing time to pain freedom (secondary endpoint) in the INTERCEPT clinical trial

^a: INTERCEPT was a randomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura, in which patients took a single dose of SYMBRAVO. 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).¹ P-values were based on chi-squared test. Missing data were not imputed.²

^b: Pain freedom was defined as a reduction to no headache pain.¹

Pain freedom from 2 to 24 hours^1,a

More patients taking SYMBRAVO experienced sustained pain freedom from 2 to 24 hours vs placebo.¹

Sustained pain freedom 2 to 24 hours (secondary endpoint)^1,b,c

Chart showing sustained pain freedom 2 to 24 hours during the INTERCEPT clinical trial

^a: INTERCEPT was a randomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura, in which patients took a single dose of SYMBRAVO. 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).¹ Missing data were not imputed.² P-value was not adjusted for multiplicity and is therefore not presented for 24-hour sustained pain freedom.

^b: Pain freedom was defined as a reduction to no headache pain.¹

^c: 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

Most patients taking SYMBRAVO did not use rescue medication from 2 to 24 hours^1,a

Rescue medication use from 2 to 24 hours (secondary endpoint)¹

Chart showing rescue medication use within 24 hours (secondary endpoint) in the INTERCEPT clinical trial

Patients not getting the relief they need?

See data from the MOVEMENT 12-month, open-label extension study.

^a: INTERCEPT was a randomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura, in which patients took a single dose of SYMBRAVO. 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).¹ Missing data were not imputed.² P-value was not adjusted for multiplicity and is therefore not presented for rescue medication use within 24 hours.

SYMBRAVO was effective later in the headache phase when pain was moderate to severe¹

MOMENTUM was a randomized, double-blind, controlled trial in 1594 patients with a history of migraine with or without aura. Patients took a single dose of SYMBRAVO later in the headache phase when pain was moderate to severe.¹

MOMENTUM study design^1,a

Chart showing the study design of the MOMENTUM clinical trial

Coprimary endpoints¹

Pain freedom^b at 2 hours^c
Freedom from most bothersome symptom^d at 2 hours^c

Key secondary endpoint¹

24-hour sustained pain freedom^e

Other secondary endpoints^1,3

Time to pain relief^f
Return to normal function at 2 hours^g
Use of rescue medication within 24 hours^h

Tested in patients with conditions that can impact treatment response³

The MOMENTUM pivotal trial included patients who had a history of inadequate response or conditions that can impact treatment response.³

Baseline characteristics across treatment groups

History of inadequate treatment response³

score ≤7ⁱ
(indicates inadequate response to prior therapy)

out of 8 mean scoreⁱ
(the lower the score, the less optimal treatment response)

Risk factors for inadequate treatment response³

experienced allodynia^j

BMI ≥30 kg/m²

experienced severe migraine pain intensity

morning migraine

preventive medication use

The mean mTOQ-4 score of 3.6 indicates poor treatment response^4,i

Of patients in MOMENTUM who experienced migraine attacks when taking their previous migraine medications, the majority reported some combination of^4,i:

NOT pain free within 2 hours
NOT pain free through 24 hours
NOT comfortable enough with their medication to plan daily activities
NOT in enough control of migraine to go about their daily activities

The clinical significance of mTOQ-4 has not been established.

^a: MOMENTUM was a randomized, double-blind, placebo- and active-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. 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.^1,3

^b: Pain freedom was defined as a reduction to no headache pain.¹

^c: Patients who took rescue medication before hour 2 or who did not have an hour 2 value were treated as nonresponders.³

^d: MBS freedom was defined as the absence of the self-identified MBS (ie, photophobia, phonophobia, or nausea).¹

^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 24.³

^f: Pain relief was defined as reduction in migraine pain intensity from moderate or severe to mild or no headache pain.¹

^g: Patients rated "none" on functional disability scale (could perform all activities).³

^h: Rescue medication was only allowed 2 hours after initial treatment.¹

ⁱ: Migraine Treatment Optimization Questionnaire (mTOQ-4) is a questionnaire used to assess treatment efficacy. To be eligible for the MOMENTUM trial, patients needed mTOQ-4 scores of ≤7, indicating inadequate response to their prior migraine therapy over the preceding 4 weeks at screening.^3,4

^j: Patients scored ≥3 on the 12‐item Allodynia Symptom Checklist (ASC‐12).³

Rapid freedom from migraine pain and MBS at 2 hours^1,a,b

SYMBRAVO achieved both coprimary endpoints in a patient population with a history of inadequate response (mTOQ-4 score ≤7).¹

Pain freedom at 2 hours^1,c

Chart showing pain freedom at 2 hours in the MOMENTUM clinical trial

MBS freedom at 2 hours^1,d

Chart showing MBS freedom at 2 hours in the MOMENTUM clinical trial

Compared to placebo, more patients taking SYMBRAVO experienced freedom from photophobia (33.5% vs 23.5%) and phonophobia (40.0% vs 18.6%) at 2 hours.¹

Patients need relief they can count on

See results from the MOVEMENT 12-month, open-label extension study.

^a: MOMENTUM was a randomized, double-blind, placebo- and active-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. 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).¹ P-values were based on chi-squared test. Missing data were not imputed.³

^b: Patients who took rescue medication before hour 2 or who did not have an hour 2 value were treated as nonresponders.³

^c: Pain freedom was defined as a reduction to no headache pain.¹

^d: MBS freedom was defined as the absence of the self-identified MBS (ie, photophobia, phonophobia, or nausea).¹

Rapid results at 2 hours^1,a

Pain relief at 2 hours (secondary endpoint)^1,b

Chart showing median time to pain relief vs all comparators (secondary endpoint) in the MOMENTUM clinical trial

Ability to return to normal function at 2 hours (secondary endpoint)

~1 out of 3 of patients taking SYMBRAVO could return to normal function at 2 hours.^1,c

32.0% SYMBRAVO, 30.3% rizatriptan, 24.5% meloxicam, 21.1% placebo (P>0.01 for SYMBRAVO vs placebo)

^a: MOMENTUM was a randomized, double-blind, placebo- and active-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. 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).¹ P-values were based on chi-squared test. Missing data were not imputed.³

^b: Pain relief was defined as reduction in migraine pain intensity from moderate or severe to mild or no headache pain.¹

^c: Patients rated “none” on functional disability scale (could perform all activities).³

Lasting pain freedom from 2 to 24 hours^1,a,b

A significantly greater percentage of patients had sustained pain freedom from 2 to 24 hours vs rizatriptan.¹

Pain freedom from 2 to 24 hours (key secondary endpoint)^1,c

Chart showing pain freedom from 2 to 24 hours (secondary endpoint) during the MOMENTUM clinical trial

^a: MOMENTUM was a randomized, double-blind, placebo- and active-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. 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).¹ P-values were based on chi-squared test. Missing data were not imputed.³

^b: 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 24.³

^c: Pain freedom was defined as a reduction to no headache pain.¹

Most patients taking SYMBRAVO did not use rescue medication from 2 to 24 hours^1,a

Rescue medication use from 2 to 24 hours (secondary endpoint)¹

Chart showing rescue medication use within 24 hours (secondary endpoint) in the MOMENTUM clinical trial

Patients not getting the lasting relief they need?

See data from the MOVEMENT 12-month, open-label extension study.

^a: MOMENTUM was a randomized, double-blind, placebo- and active-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. 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).¹ Missing data were not imputed.³ P-value was not adjusted for multiplicity and is therefore not presented for rescue medication use within 24 hours.

IMPORTANT SAFETY INFORMATION

INDICATION

SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

SYMBRAVO should only be used when a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks.
SYMBRAVO is not indicated for the preventive treatment of migraine attacks.
SYMBRAVO is not indicated for the treatment of cluster headache.

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

DOSAGE AND ADMINISTRATION

The recommended dose of SYMBRAVO is one tablet as needed for the acute treatment of migraine. The maximum daily dose should not exceed one tablet. The safety and effectiveness of a second dose for the same migraine attack have not been established. The safety of treating, on average, more than 7 headaches in a 30-day period has not been established. Use for the shortest duration consistent with individual patient treatment goals.

CONTRAINDICATIONS

Ischemic coronary artery disease (CAD), coronary artery vasospasm including Prinzmetal’s angina, or other significant underlying cardiovascular disease
In the setting of CABG surgery
History of stroke or transient ischemic attack (TIA)
Hemiplegic or basilar migraine
Peripheral vascular disease
Ischemic bowel disease
Uncontrolled hypertension
Concomitant use of propranolol

Recent (within 24 hours) use of another triptan, ergotamine containing medication, or ergot-type medication
Concurrent administration, or recent discontinuation (within 2 weeks), of a MAO-A inhibitor
Known hypersensitivity to meloxicam, rizatriptan, NSAIDs, SYMBRAVO, or any of its excipients
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or NSAIDs: Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported
Patients with moderate to severe renal insufficiency at risk for renal failure due to volume depletion or who are on dialysis

WARNINGS AND PRECAUTIONS

Cardiovascular Thrombotic Events and Myocardial Infarction

: Avoid the use of SYMBRAVO in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If SYMBRAVO is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Perform a cardiovascular evaluation in triptan-naive patients with multiple cardiovascular risk factors and if satisfactory, consider administering the first dose in a medically supervised setting.

GI Bleeding, Ulceration, & Perforation

: NSAIDs, including meloxicam, a component of SYMBRAVO, can cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with meloxicam.

Arrhythmias

: Life-threatening arrhythmias, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue SYMBRAVO if these arrhythmias occur.

Cerebrovascular Events

: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5‑HT1 agonists, some resulting in fatalities. Discontinue SYMBRAVO if any of these events occur.

Before treating headaches in patients not previously diagnosed with migraine, and in patients with migraine who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

Anaphylactic Reactions

: SYMBRAVO can cause anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma. Hypersensitivity reactions, including angioedema and anaphylaxis, have also occurred in patients receiving rizatriptan. Seek emergency help if an anaphylactic reaction occurs.

Chest/Throat/Neck/Jaw Pain/Tightness, Pressure, or Heaviness

: Sensations of tightness, pain, pressure in the chest, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with SYMBRAVO and are usually non-cardiac in origin. Perform a cardiac evaluation if a cardiac origin is suspected.

Other Vasospasm Reactions

: SYMBRAVO may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. Discontinue SYMBRAVO if any of these events occur.

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists.

Hepatotoxicity

: Elevations of ALT or AST have been reported in patients taking NSAIDs. Rare, sometimes fatal cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of the warning signs and symptoms of hepatotoxicity. Discontinue immediately if clinical signs and symptoms consistent with liver disease develop and perform a clinical evaluation.

Hypertension/Increase in Blood Pressure (BP)

: NSAIDs, including meloxicam, a component of SYMBRAVO, can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Significant elevation in BP, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients with and without a history of hypertension receiving 5-HT1 agonists, including rizatriptan, a component of SYMBRAVO.

Monitor BP during the initiation of the treatment and throughout the course of therapy.

Heart Failure and Edema

: Avoid the use of SYMBRAVO in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If SYMBRAVO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Renal Toxicity and Hyperkalemia

:
Renal Toxicity - Long-term administration of NSAIDs has resulted in serious renal injury, including acute renal failure. SYMBRAVO is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency who are at risk for renal failure due to volume depletion. The renal effects may hasten the progression of renal dysfunction in patients with pre-existing renal disease.

Correct volume status in dehydrated or hypovolemic patients prior to initiating SYMBRAVO. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use. Avoid the use in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If SYMBRAVO is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

Hyperkalemia - Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.

Serious Skin Reactions

: NSAIDs, including SYMBRAVO, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Discontinue SYMBRAVO at the first appearance of skin rash or any other sign of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

: DRESS has been reported in patients taking NSAIDs, such as SYMBRAVO. Some of these events have been fatal or life-threatening. If signs or symptoms of DRESS are present, discontinue SYMBRAVO and evaluate the patient immediately.

Fetal Toxicity

: Limit use of NSAIDs, including SYMBRAVO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.

Hematologic Toxicity

: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including SYMBRAVO, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

Exacerbation of Asthma Related to Aspirin Sensitivity

: In patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

Medication Overuse Headache

: Overuse of acute migraine drugs may lead to exacerbation of headache. Detoxification and treatment of withdrawal may be necessary.

Serotonin Syndrome

: Serotonin syndrome may occur with triptans, including SYMBRAVO, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and MAOIs. Discontinue SYMBRAVO if serotonin syndrome is suspected.

Masking of Inflammation and Fever

: The pharmacological activity of SYMBRAVO in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Laboratory Monitoring

: Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically.

DRUG INTERACTIONS:

Monitor patients for bleeding who are concomitantly taking drugs that interfere with hemostasis. Analgesic doses of aspirin are not recommended.
Monitor blood pressure in patients taking ACE inhibitors, ARBs, or beta-blockers due to decreased antihypertensive effects.
Monitor for deterioration of renal function in elderly patients with renal impairment or volume depletion taking ACE inhibitors or ARBs.
Monitor for reduced diuretic efficacy in patients taking furosemide or thiazide diuretics.
Monitor lithium levels.
Monitor methotrexate levels.

USE IN SPECIFIC POPULATIONS:

NSAIDs are associated with reversible infertility. Consider withdrawal of SYMBRAVO in women who have difficulties conceiving or who are undergoing investigation of infertility.

ADVERSE REACTIONS

Most common (≥1% and greater than placebo) adverse reactions after a single dose pooled from 2 studies were somnolence (2%) and dizziness (2%).

SYM HCP ISI 03/2025

Please see full Prescribing Information, including Boxed Warning for risk of serious cardiovascular and gastrointestinal events.

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. Lipton RB, Kolodner K, Bigal ME, et al. Validity and reliability of the migraine-treatment optimization questionnaire. Cephalalgia. 2009;29(7):751-759.

Efficacy

The power to deliver rapid, long-lasting migraine pain freedom1

SYMBRAVO trials studied efficacy across the headache phase for mild or moderate to severe migraine pain1

INTERCEPT TrialRandomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura; single dose of SYMBRAVO taken1,2

MOMENTUM TrialRandomized, double-blind, placebo-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; single dose of SYMBRAVO taken1,3

SYMBRAVO was effective earlier in the headache phase when pain was still mild1

INTERCEPT study design1,a

Baseline characteristics across both treatment groups

Demographics1

Migraine impact1,2

Rapid freedom from migraine pain and MBS at 2 hours1,a,b

Pain freedom at 2 hours1,c

MBS freedom at 2 hours1,d

Pain freedom over time vs placebo1,2,a

Pain freedom over time (secondary endpoint)1,2,b

Pain freedom from 2 to 24 hours1,a

Sustained pain freedom 2 to 24 hours (secondary endpoint)1,b,c

Most patients taking SYMBRAVO did not use rescue medication from 2 to 24 hours1,a

Rescue medication use from 2 to 24 hours (secondary endpoint)1

SYMBRAVO was effective later in the headache phase when pain was moderate to severe1

MOMENTUM study design1,a

Tested in patients with conditions that can impact treatment response3

Baseline characteristics across treatment groups

History of inadequate treatment response3

Risk factors for inadequate treatment response3

The mean mTOQ-4 score of 3.6 indicates poor treatment response4,i

Rapid freedom from migraine pain and MBS at 2 hours1,a,b

Pain freedom at 2 hours1,c

MBS freedom at 2 hours1,d

Rapid results at 2 hours1,a

Pain relief at 2 hours (secondary endpoint)1,b

Lasting pain freedom from 2 to 24 hours1,a,b

Pain freedom from 2 to 24 hours (key secondary endpoint)1,c

Most patients taking SYMBRAVO did not use rescue medication from 2 to 24 hours1,a

Rescue medication use from 2 to 24 hours (secondary endpoint)1

REFERENCES

The power to deliver rapid, long-lasting migraine pain freedom¹

SYMBRAVO trials studied efficacy across the headache
phase for mild or moderate to severe migraine pain¹

INTERCEPT TrialRandomized, double-blind, placebo-controlled trial in 302 patients with a history of migraine, with or without aura; single dose of SYMBRAVO taken^1,2

MOMENTUM TrialRandomized, double-blind, placebo-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; single dose of SYMBRAVO taken^1,3

SYMBRAVO was effective earlier in the headache phase when pain was still mild¹

INTERCEPT study design^1,a

Demographics¹

Migraine impact^1,2

Rapid freedom from migraine pain and MBS at 2 hours^1,a,b

Pain freedom at 2 hours^1,c

MBS freedom at 2 hours^1,d

Pain freedom over time vs placebo^1,2,a

Pain freedom over time (secondary endpoint)^1,2,b

Pain freedom from 2 to 24 hours^1,a

Sustained pain freedom 2 to 24 hours (secondary endpoint)^1,b,c

Most patients taking SYMBRAVO did not use rescue medication from 2 to 24 hours^1,a

Rescue medication use from 2 to 24 hours (secondary endpoint)¹

SYMBRAVO was effective later in the headache phase when pain was moderate to severe¹

MOMENTUM study design^1,a

Tested in patients with conditions that can impact treatment response³

History of inadequate treatment response³

Risk factors for inadequate treatment response³

The mean mTOQ-4 score of 3.6 indicates poor treatment response^4,i

Rapid freedom from migraine pain and MBS at 2 hours^1,a,b

Pain freedom at 2 hours^1,c

MBS freedom at 2 hours^1,d

Rapid results at 2 hours^1,a

Pain relief at 2 hours (secondary endpoint)^1,b

Lasting pain freedom from 2 to 24 hours^1,a,b

Pain freedom from 2 to 24 hours (key secondary endpoint)^1,c

Most patients taking SYMBRAVO did not use rescue medication from 2 to 24 hours^1,a

Rescue medication use from 2 to 24 hours (secondary endpoint)¹