Brekiya Approved for Acute Treatment of Migraine and Cluster Headaches

The Food and Drug Administration (FDA) has approved Brekiya^® (dihydroergotamine mesylate) injection for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Brekiya consists of dihydroergotamine mesylate, an ergotamine derivative, in a single-dose autoinjector for subcutaneous administration. In patients with migraine, the therapeutic activity of dihydroergotamine is generally attributed to the agonist effects at 5-HT_1D receptors. 

Brekiya was approved through an abbreviated pathway that relies on previously reported drug data to support the application. Dihydroergotamine has been approved since 1946 and is available in both injectable and intranasal formulations.  

“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, Chief Commercial Officer, Specialty, Amneal. “Physicians are familiar with [dihydroergotamine], 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.”

Brekiya is supplied as a 1mL prefilled single-dose autoinjector containing 1mg/mL of dihydroergotamine mesylate. The product does not require refrigeration, assembly, or priming of the device. The treatment is administered subcutaneously into the skin of the middle thigh. The dose may be repeated, as needed, at 1-hour intervals to a maximum of 3mg (3 doses) in a 24-hour period. Patients should not exceed 6 doses in a week.

Regarding safety, dihydroergotamine mesylate injection has been associated with serious and/or life-threatening cardiac events including coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. Prior to initiating Brekiya, a cardiovascular evaluation is recommended. The prescribing information also includes a Boxed Warning regarding the risk of peripheral ischemia if taken with strong CYP3A4 inhibitors, as well as other contraindications. 

Brekiya is expected to be available in the second half of 2025. 

This article originally appeared on MPR