Officials with Axsome Therapeutics, Inc., a biopharmaceutical company, have announced that the FDA has approved meloxicam and rizatriptan (Symbravo) for the acute treatment of migraine with or without aura in adults.1
This treatment represents a novel approach to treating migraine that targets multiple pathways underlying a migraine attack. The approval was based on the results of the phase 3 MOMENTUM trial that treated migraine of moderate and severe pain intensity, the phase 3 INTERCEPT trial that treated migraine when the initial pain was mild, and the phase 3 MOVEMENT long-term open-label safety trial. In this comprehensive clinical program, more than 21,000 migraine attacks were treated with meloxicam and rizatriptan.
In the MOMENTUM trial, the treatment demonstrated a statistically significantly greater percentage of patients achieving pain freedom and freedom from their photophobia, phonophobia, and nausea 2 hours after dosing compared with placebo. In a head-to-head comparison, a single dose of Symbravo demonstrated statistically significant superiority compared with rizatriptan regarding sustained pain freedom, from 2 to 24 hours.
In the INTERCEPT trial, Symbravo demonstrated a statistically significantly greater percentage of patients achieving pain freedom and relief from photophobia, phonophobia, and nausea, 2 hours after dosing compared with placebo. The benefits of pain freedom at 2 hours were sustained through 24 and 48 hours for many patients.
The most common adverse reactions in the controlled studies were somnolence and dizziness, being reported each in 2% and 1% of patients in the study treatment and placebo arms, respectively.
In a prepared statement, Stewart Tepper, MD, Clinical Professor of Neurology at the Geisel School of Medicine at Dartmouth and Vice President of the New England Institute for Neurology and Headache, said, “Migraine is a debilitating condition that affects millions of Americans. Unfortunately, many patients still struggle to find an option that effectively treats their attacks and is both safe and well tolerated, which creates a great need for new migraine medicines…[this] approval by the FDA provides a new medicine for physicians and patients that was designed to target key unmet needs in the migraine treatment space.”
Susan Doughty, Executive Director of the Coalition for Headache and Migraine Patients (CHAMP), added, “The approval of Symbravo as a new acute treatment for migraine is an important step forward, offering a new option for people seeking relief. We also see this moment as an opportunity to continue to shine a bright light on migraine, fostering greater awareness and helping to dismantle the stigma that so often surrounds this disease.”
The company expects Symbravo to be commercially available in the United States in approximately 4 months.
References
Axsome Therapeutics. axsome announces FDA Approval of SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults [press release]. Published January 30, 2025. Accessed January 31, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam