TRUDHESA
TRUDHESA is an ergotamine derivative approved for the acute treatment of migraine with or without aura in adult patients. It is designed for the immediate relief of migraine attacks and is not indicated for preventive therapy. Additionally, the medication is not intended for the management of specific migraine subtypes, such as hemiplegic or basilar migraine.
How TRUDHESA Works
Dihydroergotamine, the active ingredient in TRUDHESA, works by binding with high affinity to 5-HT 1Dα and 5-HT 1Dβ receptors. The medication functions as an agonist, which means it activates these specific serotonin receptors. This agonist activity at the 5-HT 1D receptors is the primary mechanism responsible for the drug's therapeutic effect in treating migraines.
Details
- Status
- Prescription
- First Approved
- 2021-09-02
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
TRUDHESA Approval History
What TRUDHESA Treats
1 indicationsTRUDHESA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
TRUDHESA Boxed Warning
PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of TRUDHESA with strong CYP3A4 inhibitors is contraindicated [see Contraind...
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of TRUDHESA with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7.1) ]. WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS See full prescribing information for complete boxed warning. Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of TRUDHESA with strong CYP3A4 inhibitors is contraindicated. ( 4 , 5.1 , 7.1 )
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRUDHESA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRUDHESA is indicated for the acute treatment of migraine with or without aura in adults. TRUDHESA is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use : TRUDHESA is not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine. Limitations of Use TRUDHESA is not indicated for the preventive treatment of migraine. TRUDHESA is not indicated for the management of hemiplegic or basilar migraine.
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroer...
TRUDHESA Patents & Exclusivity
Patents (6 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.