On May 15, 2025, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya^® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Brekiya autoinjector provides patients with the potential for sustained pain relief in a convenient, self-administered form. It contains the same medication (DHE) used in hospitals, now in a ready-to-use device. Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.

Patients can deliver one dose subcutaneously into the middle of the thigh. This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.

DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence.

Approximately 39 million Americans are living with migraine, and up to one million with cluster headache. Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States. There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.