FDA Approves Axsome’s Symbravo for Rapid Migraine Relief

The FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults13.

Symbravo is a novel multi-mechanistic approach that targets multiple pathways underlying a migraine attack3.

A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within 2 hours, with sustained efficacy through 24 and 48 hours in some patients36.

In clinical trials, 85% and 77% of patients treated with a single dose of Symbravo did not require migraine rescue medication within 24 hours36.

Symbravo demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe)36.

The drug incorporates Axsome's MoSEIC (Molecular Solubility Enhanced Inclusion Complex) rapid absorption technology, resulting in a five times faster median time to maximum plasma concentration for meloxicam36.

Axsome expects Symbravo to be commercially available in the U.S. in approximately four months13.

The most common adverse reactions in controlled studies were somnolence and dizziness, reported in 2% and 1% of patients in the Symbravo and placebo arms, respectively36.

Symbravo is protected by a robust patent estate extending out to at least 204036.

Sources:

1. https://www.drugtopics.com/view/fda-approves-meloxicam-and-rizatriptan-for-acute-treatment-of-migraine

3. https://www.globenewswire.com/news-release/2025/01/30/3018389/0/en/Axsome-Therapeutics-Announces-FDA-Approval-of-SYMBRAVO-meloxicam-and-rizatriptan-for-the-Acute-Treatment-of-Migraine-with-or-without-Aura-in-Adults.html

6. https://www.biospace.com/press-releases/axsome-therapeutics-announces-fda-approval-of-symbravo-meloxicam-and-rizatriptan-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults