FDA approves Tosymra nasal spray for acute migraine

  • Food and Drug Administration

  • curated by Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • The FDA has approved Tosymra, a nasal spray formulation of sumatriptan, for the treatment of adults with acute migraine with or without aura.

Why this matters

  • Previously known as DFN-02, Tosymra efficacy is based on the relative bioavailability of Tosymra nasal spray compared with sumatriptan subcutaneous injection (4 mg) in healthy adults.

Key points

  • Recommended dose is 10 mg given as a single spray in 1 nostril, with a maximum dose of 30 mg in a 24-hour period.
  • Tosymra is not indicated for the preventive treatment of migraine or the treatment of cluster headache.
  • Efficacy is based on results of 3 controlled clinical trials with more than 1000 patients with migraine:
    • Onset of pain relief after a 6-mg sumatriptan injection occurred in
    • 70% achieved headache relief within 1 hour of a single 6-mg sumatriptan injection.
    • Between 65% and 82% were pain free at 2 hours.
  • Tosymra can cause cardiac problems and is not recommended for anyone at risk for heart disease.
  • Adverse effects include changes in color or sensation in fingers and toes, stomach and intestinal problems, circulatory problems in legs and feet, medication overuse headache, serotonin syndrome, increased blood pressure, hives, and seizures.
  • Not tested in pediatric patients.

Prescribing information

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