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# Promius Pharma Migraine NDA Approved
- URL: https://www.fdaweb.com/promius-pharma-migraine-nda-approved/
- Published: 2019-01-28T12:00:00.000Z
- Updated: 2026-09-15T00:57:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143238

FDA has approved a Promius Pharma NDA for Tosymra (sumatriptan nasal spray) 10 mg, indicated for the acute treatment of migraine with or without aura in adults. The company says the nasal spray is formulated using a proprietary novel excipient known as Intravail “to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action.” The drug’s most common side effects include tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.