Amneal Pharmaceuticals has launched Brekiya (dihydroergotamine mesylate) injection, marking the first commercial availability of a self-administered dihydroergotamine autoinjector for acute treatment of migraine with or without aura and cluster headaches in adults. The specialty therapy is now available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy.
Addressing Critical Unmet Medical Need
The launch addresses a significant healthcare burden, as headache disorders represent the fourth most common reason for emergency department visits in the United States, accounting for approximately 3% of all visits. Approximately 43 million Americans suffer from migraines, while about 300,000 live with cluster headaches, a rarer but equally debilitating condition affecting roughly 1 in 1,000 people.
"We are excited to introduce Brekiya autoinjector, making this innovative therapy broadly available to healthcare providers and patients," said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty at Amneal. "As the first and only self-administered, ready-to-use DHE autoinjector, Brekiya offers patients the ability to treat debilitating attacks in a convenient way and avoid visits to the emergency room."
Clinical Profile and Administration
Each Brekiya autoinjector contains a single 1-mg dose administered subcutaneously into the middle of the thigh. Patients may take up to two additional doses if symptoms persist, with a mandatory one-hour interval between injections. The maximum dosing limits are three doses (3 mg) in a 24-hour period and six doses (6 mg) in a seven-day period.
The autoinjector requires no refrigeration, assembly, or priming, offering convenience for patients experiencing acute headache episodes. While the autoinjector received FDA approval in May 2025, dihydroergotamine has been used to treat patients in emergency rooms for decades, with its initial U.S. approval dating back to 1946.
Safety Profile and Contraindications
Brekiya carries a boxed warning regarding peripheral ischemia following coadministration with strong CYP3A4 inhibitors. The warning states that serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine and strong CYP3A4 inhibitors such as protease inhibitors and macrolide antibiotics have been reported rarely.
The most common and serious adverse reactions include cardiovascular complications:
- Temporary coronary artery vasospasm
- Transient myocardial ischemia
- Heart rhythm problems including ventricular tachycardia and ventricular fibrillation
Other potentially serious side effects include stroke, Raynaud's syndrome, gastrointestinal problems, increased blood pressure, and medication overuse headache. The treatment is contraindicated in patients taking strong CYP3A4 inhibitors such as ritonavir, nelfinavir, or indinavir, and in pregnant women due to risk of preterm labor.
Market Access and Pricing
Eligible commercially insured patients may pay as little as $40 per carton, which contains four single-dose autoinjectors, with pricing applied automatically through the specialty pharmacy. To support healthcare providers, Amneal will provide field reimbursement specialists to assist with patient access, coverage, and reimbursement questions.
Clinical Context
Treatment options for cluster headaches are currently limited, making Brekiya a significant addition for this underserved population. Cluster headaches present as sudden, excruciating burning or piercing sensations on one side of the head, typically lasting between 15 minutes and several hours. Some patients experience multiple attacks daily during cluster periods.
Migraines, affecting a much larger population, can include symptoms such as nausea, light sensitivity, and fatigue lasting hours or days. The condition encompasses various subtypes, including migraine with typical aura, menstrual migraine, and hemiplegic migraine, with migraine without aura being the most common form.
The launch represents Amneal's expansion into the neurology specialty market, with the company committed to supporting providers through comprehensive education and ensuring strong patient access as the treatment becomes available nationwide.
