MIGRANAL (dihydroergotamine mesylate)
Dihydroergotamine mesylate injection is indicated for the acute treatment of migraine headaches, with or without aura, and the acute treatment of cluster headache episodes. It is intended for the termination of active headache symptoms and is not indicated for long-term prophylactic therapy. (Note: The brand name **Migranal** refers specifically to the nasal spray formulation, which is indicated only for migraine and not for cluster headaches).
How MIGRANAL Works
Dihydroergotamine binds with high affinity to 5-HT1B and 5-HT1D receptors. Its therapeutic activity in migraine is attributed to agonist effects at these receptors, which results in the constriction of inflamed intracranial blood vessels and the inhibition of pro-inflammatory neuropeptide release from trigeminal nerve endings. It also interacts with other 5-HT, adrenergic, and dopaminergic receptor subtypes.
Details
- Status
- Prescription
- First Approved
- 1997-12-08
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
MIGRANAL Approval History
What MIGRANAL Treats
2 indicationsMIGRANAL is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
- Cluster Headache
MIGRANAL Boxed Warning
PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. 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 these medicatio...
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. 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 these medications is contraindicated. (See CONTRAINDICATIONS and WARNINGS )
MIGRANAL Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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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.
MIGRANAL FDA Label Details
Indications & Usage
FDA Label (PDF)MIGRANAL is indicated for the treatment of Migraine; Cluster Headache.
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.