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The U.S. Food and Drug Administration (FDA) has granted approval to Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine, with or without aura, in adults.
This approval follows extensive clinical evaluation, including three Phase III trials involving over 21,000 migraine attacks. The MOMENTUM trial, which focused on migraines with moderate to severe pain intensity, demonstrated that Symbravo significantly increased the percentage of patients achieving pain freedom and relief from their most bothersome symptoms—photophobia, phonophobia, and nausea—within two hours of dosing. Many patients also reported sustained relief lasting up to 24 and 48 hours.
The INTERCEPT trial, targeting migraines in their early mild-pain stage, revealed similar results. Additionally, the MOVEMENT trial, a long-term open-label safety study involving 706 patients treating at least two migraines per month, confirmed the long-term safety profile of Symbravo. The most common adverse events observed were 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,” said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics. “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.”
Disclaimer:
This article is for informational purposes only and should not be considered medical advice. Patients should consult a healthcare professional before starting any new medication. While Symbravo has been approved by the FDA, its use should be based on a doctor’s recommendation considering individual medical history and potential side effects. For more information, please visit the official FDA or Axsome Therapeutics website.
