The FDA approved dihydroergotamine (DHE) mesylate injection (Brekiya) to treat acute migraine (with or without aura) and cluster headaches in adults, Amneal Pharmaceuticals announced
The prefilled syringe formulation is the first DHE auto-injector that patients can self-administer in a ready-to-use form, according to Amneal.
The injector does not require refrigeration, assembly, or priming. "Patients can deliver one dose subcutaneously into the middle of the thigh," the company said. "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."
DHE is a migraine-specific acute medication first approved in 1946. It comes in several forms, including nasal sprays, injection, intravenous infusion, and a recently approved nasal powder. DHE can relieve pain associated with cluster headache attacks, particularly when administered intravenously.
Prescribing information for the DHE mesylate auto-injector includes a boxed warning about serious or life-threatening peripheral ischemia associated with using DHE concomitantly with strong CYP3A4 inhibitors, including protease inhibitors and macrolide antibiotics. CYP3A4 inhibition elevates serum DHE levels, raising the risk of vasospasm leading to cerebral ischemia or ischemia of the extremities.
Serious cardiac events reported with DHE mesylate injection use include coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. Some cardiac events have been fatal.
DHE is contraindicated with concomitant use of strong CYP3A4 inhibitors and in people with ischemic heart disease or coronary artery vasospasm, uncontrolled hypertension, peripheral arterial diseases, sepsis, or following vascular surgery or severe hepatic or renal impairment. People with hypersensitivity to ergot alkaloids and those who have concomitant use of 5-HT1 agonists or ergotamine-containing or ergot-type medications within 24 hours, or concomitant use of peripheral and central vasoconstrictors, should not take the drug.
The drug label also carries warnings for medication overuse headache, preterm labor, and fibrotic complication.
Approximately 39 million people in the U.S. have migraine and up to 1 million have cluster headache, Amneal noted. There are limited treatment options for cluster headache.
In 2024, the FDA rejected the DHE mesylate auto-injector, citing problems after a facility inspection at a third-party site. The newly approved product will be available in the second half of 2025, Amneal said.
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