FDA Approves First-Ever DHE Auto-Injector for Migraine and Cluster Headache Relief
In a groundbreaking development for migraine and cluster headache sufferers, the US Food and Drug Administration (FDA) has approved Brekiya (dihydroergotamine mesylate) injection, developed by Amneal Pharmaceuticals, as a treatment for acute migraine and cluster headaches in adults.
The therapy marks a major advancement in headache care as it becomes the first-ever dihydroergotamine (DHE) auto-injector to receive FDA approval.
Reimagining a Trusted Treatment
Brekiya delivers a tried-and-tested drug – DHE, commonly used in emergency settings – through a novel, patient-friendly format.
Traditionally administered intravenously in hospitals or urgent care centres, DHE is known for its rapid onset and ability to reduce headache recurrence. With the new auto-injector format, eligible patients will, for the first time, be able to self-administer a therapeutic dose of DHE at home or on the go, offering newfound convenience and autonomy.
The Brekiya device is designed for single-use, subcutaneous injection into the thigh. It arrives fully assembled, requires no refrigeration, and is ready to use during painful headache episodes – removing the barriers of hospital visits and complex preparation during already distressing moments.
Addressing a Widespread Burden
Migraine affects an estimated 39 million people in the United States and is listed by the World Health Organization as one of the most common neurological disorders globally.
Symptoms include intense, throbbing pain, nausea, vomiting, and heightened sensitivity to light and sound. Meanwhile, cluster headaches, which afflict around one million Americans, are characterised by excruciating, recurring pain usually centred around one eye. Both conditions can significantly impair quality of life.
By providing a fast-acting, hospital-grade medication in a portable and accessible form, Brekiya holds promise for transforming how patients manage their conditions.
According to Amneal’s Senior Vice President and Chief Commercial Officer – Specialty, physicians are already familiar with the efficacy of DHE. The new delivery format adds significant value, with their single-dose auto-injector representing an innovative therapeutic option that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room.
Looking Ahead
Brekiya is expected to be commercially available in the second half of 2025 for eligible patients. Its approval opens a new chapter in the treatment of debilitating headache disorders, empowering patients with a clinically robust, self-managed option when it matters most.
As the demand grows for convenient and reliable therapies for chronic neurological conditions, Brekiya’s approval not only fills a long-standing gap but also reflects a wider movement in healthcare towards patient-centred innovation.
For millions living under the shadow of migraine and cluster headaches, this development brings renewed hope for fast relief – and freedom from hospital walls.
News Credits: FDA approves Amneal’s self-administered migraine drug Brekiya
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