FDA Approves Brekiya, First and Only DHE Autoinjector, for Acute Treatment of Migraine, Cluster Headaches

The FDA approved a dihydroergotamine (DHE) mesylate injection (Brekiya; Amneal Pharmaceuticals), the first and only DHE autoinjector for acute treatment of migraine with or without aura and cluster headaches in adult patients. DHE is the same medication used in hospitals and emergency rooms (ERs), and with an approved autoinjector, patients are able to receive the medication in a ready-to-use device without the need for hospitalizations or ER visits.¹

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Approximately 39 million Americans are living with migraine, and the American Migraine Foundation reports that it is the second leading cause of disability worldwide (defined by time lost to disability) and the most common cause of disability among young women.² Further, up to 1 million live with cluster headache. Unlike migraines, cluster headaches occur as frequent attacks (referred to as “clusters”), which result in intense pain in or around the eye or 1 side of the head. These attacks can last for weeks to months.^1-3

Headache is the fourth most common reason for ER visits, accounting for approximately 3% of ER visits in the United States. In addition to ERs, DHE is commonly intravenously administered in urgent care facilities and headache clinics. The medication can be used at any point during a migraine attack and may protect patients from recurrent headaches. Treatment options for cluster headache have been rather limited, and the Brekiya autoinjector represents a new treatment option for this patient population.^1,4,5

The Brekiya autoinjector can provide patients with the potential for sustained pain relief in a self-administered form that is more convenient than visiting the hospital or ER. Additionally, the autoinjector is ready to use, meaning it does not require refrigeration, assembly, or priming of the device. Patients can deliver 1 dose subcutaneously into the middle of the thigh. The autoinjector may be beneficial for patients who do not respond adequately to oral therapies because of lack of efficacy, nausea or vomiting during attacks, gastroparesis, or delayed dosing until too late into the attack.¹

Of note, this is another approval of a new formulation of DHE for the acute treatment of migraine with or without aura in adults. On April 30, 2025, the FDA approved Atzumi (Satsuma Pharmaceuticals), a nasal powder formulation of DHE for adult patients. Similarly to Brekiya, Atzumi is marketed as an easy-to-use carriable device, enhancing accessibility and efficiency for patient use. Atzumi’s approval was supported by findings from a phase 1 pharmacokinetics trial (NCT03874832) and the phase 3 ASCEND trial (NCT04406649).^1,2

The manufacturers caution that the Brekiya autoinjector is not used to prevent migraines or to treat other types of headaches, such as hemiplegic migraines (inability to move on 1 side of the body) or basilar migraines (rare form of migraine with aura). Additionally, it is currently unknown if the Brekiya autoinjector is safe and effective in children; therefore, further research is needed to investigate this population.¹

“We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,” Joe Renda, senior vice president and chief commercial officer, specialty of Amneal Pharmaceuticals, said in a news release.¹

REFERENCES

1. GlobeNewswire. Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for the Acute Treatment of Migraine and Cluster Headaches in Adults. News release. May 15, 2025. Accessed May 15, 2025. https://www.globenewswire.com/news-release/2025/05/15/3082078/0/en/Amneal-Receives-U-S-FDA-Approval-for-Brekiya-dihydroergotamine-mesylate-injection-for-the-Acute-Treatment-of-Migraine-and-Cluster-Headaches-in-Adults.html

2. McGovern G. FDA Approves Atzumi, Nasal Powder Formulation of DHE, for Acute Treatment of Migraine. Pharmacy Times. May 1, 2025. Accessed May 15, 2025. https://www.pharmacytimes.com/view/fda-approves-atzumi-nasal-powder-formulation-of-dhe-for-acute-treatment-of-migraine

3. Mayo Clinic. Cluster headache. Accessed May 15, 2025. https://www.mayoclinic.org/diseases-conditions/cluster-headache/symptoms-causes/syc-20352080

4. Silberstein SD, Shrewsbury SB, Hoekman J. Dihydroergotamine (DHE) - Then and Now: A Narrative Review. Headache. 2020;60(1):40-57. doi:10.1111/head.13700

5. Phelan MP, Thompson NR, Ahmed Z, et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63(4):472-483. doi:10.1111/head.14456