Amneal Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Brekiya (dihydroergotamine mesylate) injection, marking a significant advancement in headache treatment. This approval represents the first and only DHE autoinjector for the acute treatment of migraine with or without aura and cluster headaches in adult patients.
The ready-to-use autoinjector allows patients to self-administer the same medication commonly used in hospital and emergency room settings, potentially reducing the need for costly and time-consuming medical visits. The product is expected to be available for appropriate patients in the second half of 2025.
Clinical Significance and Patient Impact
Migraine affects approximately 39 million Americans and is the second leading cause of disability worldwide, particularly among young women. Additionally, up to 1 million Americans live with cluster headache, a condition characterized by extremely painful attacks occurring in clusters that can last for weeks to months.
"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 of 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."
Headache is the fourth most common reason for emergency department visits, accounting for approximately 3% of all ER visits in the United States. DHE is commonly administered intravenously in emergency rooms, urgent care facilities, and headache clinics. The medication can be used at any point during a migraine attack and may protect patients from headache recurrence.
Product Features and Administration
The Brekiya autoinjector offers several practical advantages:
- Ready-to-use device requiring no refrigeration, assembly, or priming
- Subcutaneous administration into the middle of the thigh
- Each autoinjector contains one dose (1 mg)
- If headache returns after the first complete dose, patients may administer up to 2 more doses as needed, waiting at least one hour between doses
- Maximum dosing: 3 doses (3 mg) in a 24-hour period or 6 doses (6 mg) in a 7-day period
The autoinjector may be particularly 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.
Treatment Landscape and Alternatives
This approval follows the recent FDA approval of Atzumi (Satsuma Pharmaceuticals) on April 30, 2025, a nasal powder formulation of DHE also indicated for the acute treatment of migraine with or without aura in adults. Atzumi's approval was supported by findings from a phase 1 pharmacokinetics trial and the phase 3 ASCEND trial.
For cluster headache patients, treatment options have historically been limited, making Brekiya a particularly valuable addition to the therapeutic arsenal for this underserved population.
Safety Considerations
Brekiya is contraindicated in patients taking strong CYP3A4 inhibitors, including protease inhibitors and macrolide antibiotics, due to the risk of serious or potentially life-threatening reductions in blood flow to the brain or extremities.
Other contraindications include:
- Heart problems or uncontrolled high blood pressure
- Peripheral vascular disease
- Sepsis, vascular surgery, or severe liver or kidney problems
- Allergy to dihydroergotamine, ergot alkaloids, latex, or any ingredients in Brekiya
- Recent use (within 24 hours) of certain migraine medications including sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines
Healthcare providers should evaluate patients for cardiovascular risk factors before prescribing Brekiya, and certain patients should receive their first dose in a medical setting.
Looking Forward
The approval of Brekiya represents a significant step forward in migraine and cluster headache management, offering patients a convenient option for self-administration of a proven therapy. By providing the same medication used in hospitals in an accessible format, Brekiya may help reduce emergency room visits while providing effective relief for these debilitating conditions.
As the product becomes available in the latter half of 2025, healthcare providers will have an important new tool to offer patients suffering from these painful and disruptive headache disorders.
