Overview
A 9,10alpha-dihydro derivative of ergotamine. Dihydroergotamine is used as an abortive therapy for migraines. Its use has largely been supplanted by triptans in current therapy due to the class's greater selectivity and more favourable side effect profile. Recent improvements have been made in the design of intranasal delivery devices allowing for greater delivery of dihydroergotamine solution to the vasculature-rich upper nasal cavity. The recently approved Precision Olfactory Delivery technology developed by Impel Neuropharma technology has correlated with an increase of 3-fold in Cmax and 4-fold in AUC despite the solution formulated at 75% of the strength of the existing intranasal product.
Background
A 9,10alpha-dihydro derivative of ergotamine. Dihydroergotamine is used as an abortive therapy for migraines. Its use has largely been supplanted by triptans in current therapy due to the class's greater selectivity and more favourable side effect profile. Recent improvements have been made in the design of intranasal delivery devices allowing for greater delivery of dihydroergotamine solution to the vasculature-rich upper nasal cavity. The recently approved Precision Olfactory Delivery technology developed by Impel Neuropharma technology has correlated with an increase of 3-fold in Cmax and 4-fold in AUC despite the solution formulated at 75% of the strength of the existing intranasal product.
Indication
Dihydroergotamine (DHE) in all formulations is indicated for the acute treatment of migraine with or without aura in adults. As an injection, DHE is also indicated for the acute treatment of cluster headache episodes. DHE is not indicated for migraine prevention or the management of hemiplegic or basilar migraine.
Associated Conditions
- Cluster Headache
- Migraine Headache, With or Without Aura
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/28 | Phase 1 | Completed | |||
2022/04/20 | Phase 1 | Completed | |||
2021/06/25 | Phase 3 | Completed | |||
2020/05/28 | Phase 3 | Completed | |||
2019/04/03 | Phase 3 | Completed | |||
2019/03/21 | Phase 2 | Terminated | Kimberly S Jones | ||
2019/03/14 | Phase 1 | Completed | |||
2018/01/17 | Phase 1 | Completed | Impel Pharmaceuticals | ||
2011/11/09 | Phase 1 | Completed | |||
2010/09/13 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cipla USA Inc. | 69097-503 | NASAL | 4 mg in 1 mL | 1/24/2024 | |
| Padagis US LLC | 0574-0850 | SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS | 1 mg in 1 mL | 8/20/2018 | |
| Bausch Health US, LLC | 0187-0245 | NASAL | 4 mg in 1 mL | 9/1/2022 | |
| Advagen Pharma Ltd | 72888-096 | NASAL | 4 mg in 1 mL | 7/5/2023 | |
| Hikma Pharmaceuticals USA Inc. | 24201-463 | NASAL | 4 mg in 1 mL | 4/24/2023 | |
| Gland Pharma Limited | 68083-466 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 1 mg in 1 mL | 8/22/2023 | |
| Sagent Pharmaceuticals | 25021-609 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 1 mg in 1 mL | 5/2/2022 | |
| Exelan Pharmaceuticals, Inc. | 76282-680 | NASAL | 4 mg in 1 mL | 12/10/2020 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9151 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 1 mg in 1 mL | 3/17/2023 | |
| Provepharm Inc. | 81284-411 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 1 mg in 1 mL | 8/24/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||