The FDA recently approved Atzumi™ (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura. According to the manufacturer, Atzumi is the first and only DHE nasal powder for the acute treatment of migraine in an easy-to-use, easy-to-carry device.
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.
The FDA’s approval for Atzumi is based on two clinical studies; a Phase 1 PK trial and an ASCEND Phase 3 open-label, long-term safety trial. These studies demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine.
Since its approval in 1946, DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE.
Common adverse reactions for Atzumi include rhinitis, nausea/vomiting, altered sense of taste, application site reaction, dizziness, somnolence, pharyngitis, and diarrhea. Atzumi is not indicated for the preventive treatment of migraine, or for the management of hemiplegic migraine, or migraine with brainstem aura.
Atzumi can cause serious or life-threatening peripheral ischemia if co-administered with strong CYP3A4 inhibitors. Atzumi may cause cardiac events in patients with risk factors for coronary artery diseases.
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