SYMBRAVO (meloxicam)
SYMBRAVO is a combination of meloxicam and rizatriptan indicated for the acute treatment of migraine with or without aura in adults. The medication is intended for use only in patients with a confirmed migraine diagnosis and is not indicated for preventive treatment or cluster headaches. If a patient does not respond to the initial treatment, the diagnosis should be reconsidered before administering the drug for subsequent attacks.
How SYMBRAVO Works
SYMBRAVO utilizes the combined mechanisms of meloxicam and rizatriptan to treat migraine symptoms. Meloxicam inhibits cyclooxygenase enzymes to reduce the production of prostaglandins, which are mediators of inflammation that sensitize afferent nerves. Rizatriptan binds to 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system to exert its therapeutic effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-01-30
- Patent Cliff
- 2045
- Routes
- ORAL
- Dosage Forms
- TABLET
SYMBRAVO Approval History
What SYMBRAVO Treats
1 indicationsSYMBRAVO is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
SYMBRAVO Boxed 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 [see Warnings & Precautions (5.1) ] . SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) , Warning...
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 [see Warnings & Precautions (5.1) ] . SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) , Warnings & Precautions (5.1) ] . 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 [see Warnings & Precautions (5.2) ] . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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 (5.1) . SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ). 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 ( 5.2 ).
SYMBRAVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SYMBRAVO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04115098 results posted | HSC-MS-19-0677 KL2TR003168 | Ph 2 | terminated | Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials |
| NCT01147289 Dextra | EF 102 | Ph 3 | completed | Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain |
| NCT05974501 results posted | 20230147 | Ph 4 | completed | Pre vs Post Block in Total Knee Arthroplasty (TKA) |
| NCT03896009 MOMENTUM results posted | AXS-07-301 | Ph 3 | completed | Maximizing Outcomes in Treating Acute Migraine |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT02706054 | MELO-RCT | Ph 3 | completed | Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT02078102 results posted | IUCRO-0419 CA182947, 1312925163 | Ph 2 | completed | A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma |
| NCT03473665 results posted | AAAR3505 | Ph 4 | terminated | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis |
| NCT02003625 results posted | 13-195 | Ph 2 | completed | Meloxicam vs Placebo for Mobilization |
| NCT02255045 | AVM002 | Ph 2, Ph 3 | completed | Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea |
| NCT02298218 | 4-2008-0597 | Ph 4 | completed | Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SYMBRAVO FDA Label Details
Indications & Usage
FDA Label (PDF)SYMBRAVO is indicated for the treatment of Migraine.
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 tre...
SYMBRAVO Patents & Exclusivity
Patents (82 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SYMBRAVO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2045
- • 82 active patents
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment