The Food and Drug Administration (FDA) has approved dihydroergotamine (DHE) nasal powder 5.2 mg for the acute treatment of migraine in adults with or without aura. The new product is currently the only DHE nasal powder available for this indication, according to a press release from manufacturer Satsuma. Clinical studies demonstrated that the formulation offers rapid absorption, quick attainment of high plasma DHE concentrations, and sustained levels over time. It was generally well tolerated both for long-term and as-needed use. The DHE ingredient first gained FDA approval in 1946. This newly approved intranasal DHE formulation can be administered at any stage of a migraine episode, and the delivery mechanism has an advantage over previous liquid nasal sprays and injectable DHE products that were cumbersome to use, according to the company.
With some precautions: Prescribing information can be found in the announcement and includes a boxed warning regarding the risk of serious or life-threatening peripheral ischemia when used in combination with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of DHE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Providers should consult the prescribing information for other contraindications.
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