Amneal Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Brekiya (dihydroergotamine mesylate) injection to treat migraine and cluster headaches.
Brekiya is the marks the first dihydroergotamine mesylate (DHE) autoinjector for the acute treatment of migraines, with or without aura, and cluster headaches in adults.
The autoinjector device offers a self-administered option for patients, using the same medication typically administered in hospitals.
Brekiya provides a convenient, ready-to-use solution that does not require refrigeration, assembly, or priming, and the autoinjector is set to be launched in the latter half of 2025.
Patients can self-administer a dose subcutaneously into the thigh, potentially benefiting those who do not respond well to oral therapies or experience nausea during attacks.
DHE is a common treatment in emergency rooms and headache clinics, often administered intravenously, and can be used for any stage of a migraine attack and headache recurrence.
Brekiya represents a new treatment option for cluster headaches, an area with limited available therapies.
The medication is not recommended for use with strong CYP3A4 inhibitors, such as protease inhibitors and macrolide antibiotics.
Brekiya is not intended for the prevention of migraines or for treating headache types other than the indicated, and its safety or effectiveness is not established for use in children.
Amneal senior vice president and specialty chief commercial officer Joe Renda said: “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.
“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.”
Recently, Amneal and medical technology firm Apiject Systems have announced a partnership aimed at enhancing domestic production capabilities.
The collaboration will focus on expanding Apiject’s blow-fill-seal (BFS) injectable platform at Amneal’s Brookhaven facility in New York.
It aims to strengthen the capacity for producing a variety of sterile drug dosage forms, including prefilled injectables, ophthalmics, and inhalation products.
