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Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.
Impel NeuroPharma, a biopharmaceutical company, announced on Sept. 3, 2021, that FDA approved Trudhesa (dihydroergotamine mesylate) nasal spray for acute treatment of adults with or without aura.
Trudhesa delivers dihydroergotamine mesylate (DRE) to the bloodstream through the nasal space. Because the nasal passage is vascular-rich, this is intended to offer rapid symptom relief even if it is administered hours after the onset of a migraine without the need for an injection or infusion, according to a company press release.
This approval comes on the heels of a Phase III, open-label, pivotal safety study, with the primary objective of assessing the safety and tolerability of Trudhesa. Over 5650 migraine attacks were treated over 24 or 52 weeks during the study. According to the press release, the results found that it was generally well tolerated, while exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief.
“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, in the press release. “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 [Precision Olfactory Delivery] POD technology.”
Source: Impel Neuropharma