New Multi-Pathway Migraine Therapy SYMBRAVO Reaches U.S. Patients Following FDA Approval

Axsome Therapeutics has launched SYMBRAVO (meloxicam and rizatriptan), a prescription combination therapy that combines an NSAID with a triptan to address migraine attacks affecting over 40 million Americans. The medication represents an innovative approach leveraging Axsome’s proprietary MoSEIC™ technology to enable rapid drug absorption while maintaining therapeutic effectiveness through 24 hours after a single dose.

Clinical Benefits Address Unmet Patient Needs

Among the 40 million Americans experiencing migraine—including 31.5 million women—a significant treatment gap remains. Recent patient surveys reveal that 63% of migraine sufferers express dissatisfaction with their current therapeutic options. SYMBRAVO provides clinically meaningful advantages: patients experienced pain relief within 2 hours compared to placebo, with pain freedom sustained throughout the day in certain patients.

The medication targets multiple neurological pathways simultaneously. Meloxicam functions as a COX-2 preferential NSAID, while rizatriptan acts as a 5-HT1B/1D receptor agonist. This dual-mechanism strategy differentiates SYMBRAVO from single-action migraine treatments available today.

Comprehensive Patient Access Program

Recognizing the importance of medication accessibility, Axsome established SYMBRAVO On My Side, a patient support initiative designed to reduce financial barriers. The program includes prescription savings cards for commercially insured patients, educational resources, and tools facilitating conversations between patients and healthcare providers. The maximum daily dose is one tablet, taken whole without crushing or chewing.

Important Safety Considerations for Users

SYMBRAVO carries cardiovascular and gastrointestinal risk warnings consistent with NSAID-containing products. Patients should not use this medication if they have experienced recent heart attacks, strokes, or take beta-blockers like propranolol. The therapy remains contraindicated for hemiplegic or basilar migraine subtypes and is not approved for cluster headaches or pediatric populations.

The most commonly reported adverse effects include dizziness and fatigue. Serious but uncommon complications may involve heart arrhythmias, elevated blood pressure, gastrointestinal bleeding, or allergic skin reactions. Patients taking SSRIs or SNRIs should discuss potential serotonin syndrome risks with their physician.

Clinical Context and Disease Burden

According to 2019 Global Burden of Disease data, migraine ranks as the second leading cause of disability worldwide, underscoring the therapeutic significance of new treatment options. The condition characteristically produces pulsating, often severe head pain accompanied by nausea, photosensitivity, and sound sensitivity—symptoms that frequently interfere with work and daily functioning.

Healthcare providers considering SYMBRAVO should review comprehensive prescribing information and the medication guide, conduct cardiovascular assessments in at-risk patients, and discuss contraindications thoroughly before prescribing. Patients should report all current medications, including over-the-counter products, to prevent unintended NSAID duplication.

For detailed information about SYMBRAVO, patients may contact Axsome at 866-496-2976 or visit the official medication website. Healthcare professionals and patients are encouraged to review the complete prescribing information, including boxed warnings regarding serious cardiovascular and gastrointestinal adverse events, before initiating therapy.

Axsome Therapeutics continues advancing its neuroscience portfolio addressing central nervous system disorders affecting over 150 million Americans, with existing FDA-approved treatments for depression, narcolepsy, obstructive sleep apnea-related sleepiness, and now acute migraine management.