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June 19, 2025

Brekiya Approved for the Acute Treatment of Migraine

The FDA has approved Brekiya® (dihydroergotamine mesylate) injection for the acute treatment of migraine with or without aura, and the acute treatment of cluster headaches.

DHE has been used to treat migraines since its initial approval in 1946 and has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine, with significant advantages versus other anti-migraine treatments for many patients. However, invasive and burdensome administration and/or sub-optimal clinical performance has historically limited the widespread use of DHE.

According to the manufacturer, Brekiya is the first and only ready-to-use autoinjector for Dihydroergotamine (DHE) that allows patients to self-administer the same medication used in hospitals settings.

This new approval, in addition to a recent nasal powder formulation of DHE, offers patients a new way to administer DHE, increasing prescription drug options for the treatment of acute migraines.

Brekiya is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. Brekiya is contraindicated in patients using CYP3A4 inhibitors, those with certain cardiovascular conditions, among patients using other ergot-type medications, and in other scenarios. Adverse reactions include serious (including fatal) cardiac events.

In workers’ comp, migraines can arise as the result of traumatic head injury, or certain injuries can exacerbate preexisting migraine conditions, making migraine medications a growing component of workers’ comp drug therapy.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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