FDA OKs Impel NeuroPharma's Trudhesa

Trudhesa is a nasal spray used for the acute treatment of migraine with or without aura in adults.
Sandra Levy
Senior Editor
Sandra Levy profile picture

Impel NeuroPharma has received permission from the Food and Drug Administration for Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults.

The company noted that through its proprietary Precision Olfactory Delivery technology, Trudhesa gently delivers dihydroergotamine mesylate—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich upper nasal space.

[Read more: Teva Launches Ajovy auto injector device for migraine

“We are delighted with the approval of Trudhesa and are proud to offer the millions of Americans with migraine a non-oral, acute treatment option that may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack,” said Adrian Adams, chairman and CEO of Impel NeuroPharma.

He added, “The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology. We are grateful for all the patients and investigators who participated in our clinical trials and who were instrumental in bringing this needed advancement to the migraine community.”

A commercial launch of the medication is planned for early October 2021.