FDA Approves DHE Autoinjector for At-Home Treatment of Migraine and Cluster Headache

The Food and Drug Administration (FDA) has approved the Brekiya (dihydroergotamine [DHE] mesylate; Amneal Pharmaceuticals, Bridgewater, NJ) autoinjector for the acute treatment of migraine with and without aura and cluster headache in adults. According to a statement by Amneal Pharmaceuticals, Brekiya is the first FDA-approved DHE autoinjector, expanding treatment options for people who may benefit from non-oral delivery routes.

The Brekiya autoinjector delivers a single dose of DHE subcutaneously for headache relief, enabling at-home treatment using the same medications people with migraine and cluster headache receive in the hospital setting. Injections are administered to the center of the patient’s thigh, and the device does not require priming, assembly, or refrigeration. In their press release, the company states that Brekiya may be a beneficial option for people who have difficulty using oral medications for headache treatment due to a lack of effectiveness, gastrointestinal side effects, or those who delay taking medications until too late into an attack.

“We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches,” said Joe Renda, Senior Vice President and Chief Commercial Officer—Specialty at Amneal Pharmaceuticals. “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.”

Amneal Pharmaceuticals notes that Brekiya should not be used by patients who are taking strong CYP3A4 inhibitors. Brekiya’s label includes a Boxed Warning for peripheral ischemia following coadministration with strong CYP3A4 inhibitors.