Monday, February 10, 2025

FDA Approves SYMBRAVO for Rapid Migraine Relief

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Key Takeaways

  • The FDA has approved Axsome Therapeutics’ SYMBRAVO for acute migraine treatment.
  • SYMBRAVO provides rapid and sustained relief, reducing the need for rescue medication.
  • Axsome’s new drug targets multiple migraine pathways, improving treatment options.

Axsome Therapeutics has secured U.S. Food and Drug Administration (FDA) approval for SYMBRAVO (meloxicam and rizatriptan), a novel treatment for acute migraines with or without aura in adults. The approval introduces a new multi-mechanistic approach that targets multiple pathways involved in migraine attacks, offering rapid pain relief and sustained efficacy.

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SYMBRAVO demonstrated superior efficacy in clinical trials, showing pain freedom within two hours and relief lasting up to 48 hours. The Phase 3 trials revealed that 85% and 77% of patients did not require rescue medication within 24 hours post-dose. This breakthrough could address the unmet needs of many migraine sufferers who struggle with ineffective existing treatments.

Phase 3 Clinical Trials

The approval is based on robust Phase 3 clinical trials, including the MOMENTUM and INTERCEPT studies. SYMBRAVO outperformed placebo and demonstrated statistical superiority in reducing migraine pain across all severity levels. Notably, its rapid absorption technology ensures faster therapeutic action, distinguishing it from traditional migraine treatments.

Medical experts have hailed the approval as a major advancement. Dr. Richard B. Lipton from Albert Einstein College of Medicine emphasized the importance of new treatment options for patients with inadequate responses to existing therapies. Similarly, Dr. Stewart Tepper from Dartmouth highlighted the need for safer and more effective migraine treatments, underscoring SYMBRAVO’s potential impact.

Beyond its clinical benefits, SYMBRAVO aims to improve patient quality of life by minimizing disruption caused by migraines. Axsome Therapeutics expects the drug to be available in the U.S. market within four months, providing a new hope for millions of patients suffering from debilitating migraine episodes.

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