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
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