Innovative Brekiya® DHE Autoinjector Launched by Amneal for Rapid Relief of Migraine and Cluster Headaches

Amneal Pharmaceuticals has announced the U.S. commercial launch of Brekiya® (dihydroergotamine mesylate) injection, marking a significant advancement in the treatment of migraine and cluster headaches. Brekiya is the first and only ready-to-use dihydroergotamine (DHE) autoinjector approved for the acute treatment of migraine attacks, with or without aura, and cluster headaches in adults. Available exclusively by prescription through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy, this innovative product offers patients a convenient, self-administered alternative treatment option previously limited to hospital settings.​

Addressing Urgent Need in Headache Management

Migraines rank one of the leading causes of disability globally, especially among young women. Cluster headaches, though rarer with about 300,000 affected individuals in the U.S., cause excruciating pain and frequent attacks lasting weeks to months. These headache disorders also contribute to approximately 3% of emergency department visits in the U.S., stressing the requirement for accessible, effective treatments.

About Brekiya

The Brekiya autoinjector represents a significant advancement in the treatment of acute migraine and cluster headaches, designed for patient convenience and ease of use in mind. Each autoinjector is prefilled with a precise 1 mg dose of dihydroergotamine mesylate, intended for subcutaneous administration in the middle of the thigh, a site that allows simple and comfortable self-injection. Patients are advised to rotate injection sites to minimize local skin irritation.

The device’s ready-to-use nature eliminates the need for refrigeration, assembly, or priming, which reduces barriers to quick and effective administration during sudden headache episodes. By simply removing the needle cap and pressing the autoinjector against the skin, users activate the injection with a push button, which delivers the full dose in about 10 seconds while ensuring needle safety by automatic retraction after injection.

This design not only enhances safety but also empowers patients to manage their symptoms at home promptly. The recommended dosing regimen allows for one initial dose and up to two additional doses spaced at least one hour apart if symptoms persist, with a maximum of three doses per 24-hour period and no more than six doses per week. This flexible dosing accommodates individual patient needs while maintaining safety limits. Overall, Brekiya provides a user-friendly, efficient, and safe solution for adults seeking rapid relief from debilitating migraine and cluster headache attacks, potentially reducing the need for emergency care visits.

Approval Basis

The FDA approved Brekiya through an abbreviated new drug application pathway, which mostly depends on previous clinical data supporting DHE’s efficacy and safety since its initial approval in 1946. However, the autoinjector device itself is new; the medication’s therapeutic benefits have been demonstrated in numerous prior clinical studies like DHE has been shown to provide sustained relief from migraine attacks and cluster headache episodes, with clinical trials indicating its superiority in reducing headache recurrence compared to other treatments like sumatriptan. The autoinjector format was evaluated for usability, safety, and effective subcutaneous delivery, ensuring it maintains the drug’s therapeutic effects while enhancing patient convenience and self-administration at home. This approval represents the first FDA authorization of a ready-to-use DHE autoinjector for acute migraine and cluster headache treatment in adults, expanding access to this established therapy in a novel, user-friendly form.

Safety Profile

Dihydroergotamine (DHE), the active ingredient in Brekiya, has a well-established safety profile that has been extensively studied over decades of clinical use in treating migraines and cluster headaches. Common side effects include nausea, vomiting, dizziness, and injection site reactions such as pain or redness. More serious but less common risks involve vasoconstriction-related events, particularly in patients with cardiovascular conditions or those taking strong CYP3A4 inhibitors, where DHE can cause ischemia or other vascular complications. Therefore, it is contraindicated in patients with known coronary artery disease, peripheral vascular disease, or uncontrolled hypertension. Due to these risks, appropriate patient screening and adherence to dosing limits are essential to maximize safety.

Regarding the Brekiya autoinjector device, dedicated usability and safety studies have demonstrated that the autoinjector is safe and effective for patient self-administration.