On January 30, 2025, Axsome Therapeutics, Inc. announced the U.S. Food and Drug Administration approval of Symbravo for the acute treatment of migraine with or without aura in adults. Symbravo is not indicated for the prevention of migraine attacks or treatment of cluster headache.

Symbravo is a single-tablet combination product containing two medications: meloxicam 20 mg, a nonsteroidal anti-inflammatory drug (NSAID) and rizatriptan 10 mg, a triptan. Each single active ingredient —meloxicam and rizatriptan — is available in generic by prescription in various strengths.

According to Axsome, Symbravo should only be used where a clear diagnosis of migraine has been established. If there is no response after the first migraine attack, the diagnosis of migraine should be reconsidered before Symbravo is administered to treat any subsequent attacks. The recommended dose is one tablet as needed for the acute treatment of migraine, not to exceed one tablet per day.

• The safety and effectiveness of a second dose for the same attack have not been established.
• The safety of treating, on average, more than 7 headaches in a 30-day period has not been established.

Symbravo has the same safety warnings as other NSAIDs and triptans, including but not limited to increased risk of serious cardiovascular (e.g., heart attack, stroke) and gastrointestinal (e.g., bleeding ulcer) adverse drug events.   

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According to headache and migraine experts, certain NSAIDs (e.g., ibuprofen, naproxen) and triptans (e.g., sumatriptan, rizatriptan) are considered first-line therapy with established effectiveness in the acute treatment of migraine.

Until migraine practice guidelines are updated and if clinically appropriate, the use of generic, first-line medications should be tried prior to the use of a brand-name combination product, such as Symbravo or Treximet® (naproxen sodium and sumatriptan).

In general, brand-name combination products are higher-cost compared to generic, single ingredient products.   

For more information on Symbravo, click here.

If you have any questions, please contact your account manager, clinical liaison, or our Clinical Services team at 1-866-742-7676.

Sources:

1. Axsome Therapeutics News Release. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. January 30, 2025. Available at Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults | Axsome Therapeutics, Inc.. Accessed on February 7, 2025.
2. Ailani, J, Burch, RC, Robbins, MS; the Board of Directors of the American Headache Society (AHS). The AHS Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021;61:1021–1039.
3. Charles, AC et al. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An AHS position statement update. Headache. 2024;64:333-341.