The U.S. Food and Drug Administration has approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
The approval was based on the results of three Phase III trials of more than 21,000 migraine attacks combined. In the MOMENTUM trial, which treated migraine of moderate and severe pain intensity, Symbravo showed a statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptoms (photophobia, phonophobia, nausea) two hours after dosing versus placebo, with benefits of pain freedom sustained through 24 and 48 hours for many patients.
In the INTERCEPT trial, which treated migraine when the initial pain was mild, similar results were seen. Finally, in the MOVEMENT long-term open-label safety trial (706 patients; treating at least two migraines per month), the long-term safety of Symbravo was shown, with the most common adverse events being somnolence and dizziness.
“Migraine attacks strike without warning, and disrupt the lives of an estimated more than 39 million patients in the U.S. alone,” Herriot Tabuteau, M.D., CEO of Axsome Therapeutics, said in a statement. “Symbravo provides patients and clinicians with an important new option which can quickly stop a migraine attack, keep it away, and allow patients to resume their normal activities, with just a single dose.”
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FDA approves Symbravo for acute treatment of migraine in adults (2025, February 6)
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