Amneal Receives U.S. FDA Approval for Brekiya®? (Dihydroergotamine Mesylate) Injection for the Acute Treatment of Migraine and Cluster Headaches in Adults

Published: 2025-05-15 08:00:00 ET AMRX

Published on 05/15/2025 at 08:00, updated on 05/15/2025 at 09:05

Amneal Pharmaceuticals, Inc. 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 autoinjectionor 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 migraine7, 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 autoinjectors represents a new treatment option for this underserved population.2 do not take Brekiya autoinjecter with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics.

See additional Important Safety Information below. Brekiya autoin injector is a prescription medicine used for the acute treatment of migraine With or without aura and acute cluster headaches in adults. Breakiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as migraine migraines (that make unable to move on one side of body) or basilar migraines (rare form of migraine with aura).

These are not all of the possible side effects of Brekiya autoinject or freeze. Call healthcare provider for medical advice about side effects. How should I store Brekiya autoinjectOR?

Store at room temperature between 68degF to 77degF (20degC to 25degC). Do not refrigerate or freeze. Protect Brekiya autoinjectore or freeze.

Protect Brekiy autoinjector from light. Keep Brekiya autoinjecting in the original pack until ready to use.