The FDA has approved Brekiya (dihydroergotamine mesylate) injection, marking a significant advancement in the acute treatment of migraine and cluster headaches in adults. Developed by Amneal Pharmaceuticals, Brekiya is the first and only dihydroergotamine (DHE) autoinjector available for self-administration, offering a hospital-grade therapy in a ready-to-use, single-dose device.
Brekiya’s approval addresses a substantial unmet need, as migraines affect approximately 39 million Americans and cluster headaches impact up to 1 million. Traditionally, DHE has been administered intravenously in emergency settings, but Brekiya’s autoinjector allows patients to deliver the medication subcutaneously into the thigh at home, without the need for refrigeration, assembly, or priming. This innovation is particularly beneficial for patients who do not respond to oral therapies, experience nausea or vomiting during attacks, or delay treatment until symptoms escalate.
The device is expected to be available in the second half of 2025 and may reduce emergency room visits, as headaches are the fourth most common reason for ER admissions in the U.S. Brekiya’s convenient, self-administered format represents a meaningful step forward in migraine and cluster headache care.
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