FDA Approves Dihydroergotamine as Auto Injectable for Migraine Treatment
Dihydroergotamine (Brekiya) is an acute treatment to help relieve migraine attacks, and it can come in nasal sprays, injections, and intravenous infusions.
The FDA approved dihydroergotamine (DHE) mesylate (Brekiya) injection as the first and only dihydroergotamine autoinjection for the acute treatment of migraine or cluster headaches for adults. The approval includes migraine with or without aura.1
Dihydroergotamine (Brekiya) is an acute treatment to help relieve migraine attacks, and it can come in nasal sprays, injections, and intravenous infusions. | Image Credit: sebra - stock.adobe.com
“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,” Joe Renda, senior vice president and chief commercial officer for specialty at Amneal, said in a news release.1 “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.”
The autoinjection is the same medication that is used in the intravenous (IV) formulation for hospitals. DHE is an acute treatment to help relieve migraine attacks, and it can come in nasal sprays, injections, and IV infusions. IVs are the fastest and most effective method for DHE, but they need a medical professional to administer them. Typically, it is given in an emergency room or infusion center, but it can also be used in inpatient settings for status migrainosus, or migraine that lasts more than 72 hours, according to the American Migraine Foundation.1,2
The new formulation allows patients to administer the medication themselves. It does not require refrigeration, assembly, or priming, and it can be delivered in 1 subcutaneous dose to the middle of the thigh. The benefits of subcutaneous injections are for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing too late into the attack.1
DHE binds to 5-HT1Dα and 5-HT1Dβ receptors, and the mean maximum plasma concentration was 3.8 ng/mL. The median time from dosing to maximum plasma concentration was approximately 0.4 hours, according to the package insert. Adverse events have included serious cardiac events, including coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation.3
Drug interactions include CYP3A4 inhibitors, triptans, beta blockers, vasoconstrictors, nicotine, and selective serotonin reuptake inhibitors.3
In April 2025, Atzumi, a nasal formation of DHE, was approved by the FDA. It was approved as a nasal powder for the acute treatment of migraine with or without aura, similar to Brekiya.5
"DHE plays a unique clinical role in the acute treatment of migraine, providing patients long-lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages,” Stewart J. Tepper, MD, vice president of the New England Institute for Neurology and Headache in Stamford, Connecticut, said in a news release.5
READ MORE: Headache and Migraine Resource Center
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