FDA Approves Impel NeuroPharma’s Trudhesa

FDA has approved Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. A company announcement says Trudhesa uses the firm’s proprietary precision olfactory delivery technology to deliver the active ingredient quickly to the bloodstream through the vascular-rich upper nasal space.

“Trudhesa bypasses the gut and potential absorption issues offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack,” the announcement says.

The Trudhesa NDA included results of the Phase 3 STOP 301 study in which over 5,650 migraine attacks were treated over 24 or 52 weeks. The company says Trudhesa was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief.