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Trudhesa FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 4, 2021.

FDA Approved: Yes (First approved September 2, 2021)
Brand name: Trudhesa
Generic name: dihydroergotamine mesylate
Dosage form: Nasal Spray
Company: Impel NeuroPharma, Inc.
Treatment for: Migraine

Trudhesa (dihydroergotamine mesylate) is a nasally administered dihydroergotamine (DHE) formulation for the acute treatment of migraine with or without aura in adults.

  • Trudhesa is not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine.
  • Dihydroergotamine mesylate is a well established migraine treatment with more than 70 years of therapeutic use. Trudhesa uses advanced Precision Olfactory Delivery (POD®) technology to deliver dihydroergotamine quickly into the bloodstream through the vascular-rich the upper nasal space. 
  • The FDA approval of Trudhesa included results of the Phase 3, open-label, pivotal safety study, STOP 301. In the trial, Trudhesa was generally well tolerated with 52.3% of patients experiencing local irritative symptoms. Exploratory efficacy findings reported 38% patients had pain freedom, 66% had pain relief, and 52% had freedom from their most bothersome migraine symptom at two hours after their first dose.
  • Trudhesa is self-administered as one metered dose spray into each nostril. The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses within a 24-hour period or 3 doses within 7 days.
  • The Trudhesa product label carries a boxed warning for serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine and strong CYP3A4 inhibitors. Trudhesa may cause serious adverse reactions including myocardial ischemia and/or infarction, cerebrovascular adverse reactions and fatalities, vasospasm related adverse reactions, medication overuse headache, preterm labor, and fibrotic complications.
  • Common adverse reactions include rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.

Development Timeline for Trudhesa

DateArticle
Sep  3, 2021Approval  FDA Approves Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine
Jan 20, 2021Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance of New Drug Application for INP104 for the Acute Treatment of Migraine
Nov  9, 2020Impel Neuropharma Announces FDA Submission of New Drug Application for INP104 for the Acute Treatment of Migraine

Further information

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