What Makes SYMBRAVO – the Newly FDA-Approved Migraine Drug

FDA has approved Symbravo (meloxicam & rizatriptan) for the acute treatment of migraine with or without “aura”. Leveraging proprietary MoSEIC™ technology, Symbravo delivers rapid pain relief and long-lasting efficacy, offering renewed hope for patients with migraine.

1. FDA Approves Symbravo (meloxicam and rizatriptan) for Acute Migraine Treatment

Migraine is a serious neurological disorder characterized by recurrent, pulsating headaches. These episodes are often debilitating and can be accompanied by nausea, photophobia, and phonophobia.

Axsome Therapeutics, Inc., a leading pharmaceutical company in the field of central nervous system (CNS) disorders, announced that the FDA has approved Symbravo® (meloxicam and rizatriptan) for the acute treatment of migraine with or without “aura” in adults.

Symbravo represents a novel multi-mechanistic treatment approach, targeting multiple migraine pathophysiologic pathways. It combines meloxicam, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan, a 5-HT1B/1D receptor agonist effective in alleviating migraine pain.

The product has shown the ability to rapidly relieve migraine symptoms and restore patient functionality, with effects lasting up to 24 to 48 hours after a single dose in some patients.

Its efficacy has been demonstrated in various clinical scenarios:

At early onset of a mild headache.
In moderate to severe migraine attacks.
In patients with prior inconsistent responses to other acute migraine therapies (e.g., Triptan (Rizatriptan, Sumatriptan); NSAIDs (Ibuprofen, Naproxen)

Commercial availability in the U.S. is expected within the next four months.

2. . Dosage Form and Composition

Symbravo is formulated as a white, film-coated, oblong tablet, debossed with “MXRZ” on one side and “20/10” on the other. Each tablet contains meloxicam 20 mg and rizatriptan 10 mg, and the maximum daily dose is one tablet

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3. Patent Protection

Symbravo utilizes Axsome’s proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) rapid absorption technology. MoSEIC™ significantly enhances drug absorption, allowing meloxicam to reach peak plasma concentrations five times faster than conventional formulations, while maintaining a prolonged plasma half-life. This innovative delivery system enabled meloxicam to be classified as a New Molecular Entity (NME) in the FDA’s approval history for acute migraine treatment.

The formulation is protected under patent with exclusivity expected to extend at least through 2040.

4. Conclusion

The FDA approval of Symbravo marks an important advancement in migraine therapy, particularly for patients who have not responded well to existing treatments. Thanks to MoSEIC™ technology, Symbravo offers rapid onset and sustained efficacy for up to 24–48 hours with a single dose, presenting a promising new option to enhance the quality of life for millions of migraine sufferers. Symbravo is expected to be available on the U.S. market within the next 4 months.

Additional Information on Migraine

It is estimated that over 39 million Americans live with migraine, which ranks as the leading cause of disability among neurological disorders in the U.S., according to the American Migraine Foundation. Surveys indicate that over 70% of patients are unsatisfied with the effectiveness of currently available oral acute migraine treatments.

Stages of a Migraine Attack

- Prodrome:Hours or days before onset, may include fatigue, mood changes, food cravings, or neck stiffness.
- Aura (in some patients): Visual disturbances (flashes, temporary vision loss), numbness, speech difficulty.
- Headache phase: : Throbbing, severe headache lasting 4–72 hours, often with nausea and light/sound sensitivity.
- Postdrome: Fatigue, difficulty concentrating, or malaise following resolution of the headache.