FDA

Symbravo OK’d for acute migraine with or without aura

February 3, 2025

Brand name: Symbravo

Generic name: meloxicam and rizatriptan

Manufacturer: Axsome Therapeutics

Approval date: January 30, 2025

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

Efficacy

Approval was based on the data from the phase 3 MOMENTUM trial (NCT03896009) involving patients with migraine of moderate and severe pain intensity; the phase 3 INTERCEPT trial (NCT04163185) involving migraine patients whose initial pain was mild; and the phase 3 MOVEMENT long-term open label safety trial (NCT04068051). More than 21,000 migraine attacks were treated with Symbravo in this comprehensive clinical program.

In the MOMENTUM trial, Symbravo resulted in a statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom (photophobia, phonophobia, nausea) 2 hours after dosing compared with placebo. Symbravo also demonstrated statistical superiority for pain relief (reduction of moderate or severe pain to no pain or mild pain) and the ability to perform normal daily activities. Freedom from pain was sustained through 24 and 48 hours for many patients. In a head-to-head comparison, Symbravo demonstrated statistically significant superiority compared with rizatriptan alone on sustained pain freedom from 2 to 24 hours. In the MOMENTUM trial, 77% of patients treated with Symbravo didn’t require rescue medication within 24 hours post dose.

In the INTERCEPT trial, Symbravo resulted in a statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom (photophobia, phonophobia, nausea) 2 hours after dosing compared with placebo. Freedom from pain was sustained through 24 and 48 hours for many patients. In the INTERCEPT trial, 85% of patients treated with Symbravo didn’t require rescue medication within 24 hours post dose.

Safety

The most common adverse reactions (≥1% and greater than placebo) in the controlled trials were somnolence and dizziness, being reported each in 2% and 1% of patients in the Symbravo and placebo groups, respectively. Long-term safety was demonstrated in the MOVEMENT trial, which assessed 706 patients dosing intermittently for up to 12 months and treating at least 2 migraines per month with Symbravo.

Sources:

Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. Axsome Therapeutics. 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam

Symbravo. Package insert. Axsome Therapeutics. 2025. https://www.axsome.com/wp-content/uploads/2025/01/SYM-USPI-001.000-20250130.pdf