FDA Approves Amneal’s Brekiya: First DHE Autoinjector For Migraine And Cluster Headache Relief

Amneal Pharmaceuticals has received FDA approval for Brekiya®, the first and only dihydroergotamine (DHE) autoinjector designed for the acute treatment of migraine (with or without aura) and cluster headaches in adults. Brekiya delivers the same DHE medication used in hospitals but in a convenient ready-to-use, self-administered format that requires no refrigeration, assembly, or priming.

“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,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Speciality.

Designed for subcutaneous injection into the thigh, Brekiya offers a practical alternative for patients who suffer from nausea, gastroparesis, or delayed oral dosing during a migraine attack. It provides the potential for sustained pain relief and may reduce the risk of headache recurrence. This marks a significant innovation for patients who currently rely on intravenous DHE in emergency or urgent care settings.

With 39 million Americans affected by migraine and up to 1 million with cluster headache, Brekiya addresses a critical unmet need, particularly for cluster headache, where few treatment options exist. Given that headaches are the fourth most common cause of emergency room visits in the U.S., Brekiya could help shift care from hospitals to home, improving access and quality of life for patients.