FDA approval for Brekiya (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults - Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. announced that the FDA has approved Brekiya (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Brekiya autoinjector provides patients with the potential for sustained pain relief in a convenient, self-administered form. It contains the same medication (DHE) used in hospitals, now in a ready-to-use device. Brekiya autoinjector does not require refrigeration, assembly, or priming of the device. Patients can deliver one dose subcutaneously into the middle of the thigh. This may be 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.
       
“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 – Specialty.

DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence. Approximately 39 million Americans are living with migraine, and up to one million with cluster headache. Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States. There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.

Brekiya was approved through an abbreviated pathway, leveraging existing data on dihydroergotamine mesylate, which has been used in various formulations since its initial approval in 1946 . This pathway allowed for the approval of Brekiya without the need for new clinical trials, as the safety and efficacy of DHE were already well-established.