Impel NeuroPharma Announces U.S. FDA Approval of TRUDHESA™ (Dihydroergotamine Mesylate) Nasal Spray for the Acute Treatment of Migraine

发布时间： 2021-09-10 阅读：562次

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Sept. 03, 2021 -- Impel NeuroPharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. TRUDHESA was previously known as INP104.

In the trial, TRUDHESA was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief. Unlike some oral acute treatments that need to be taken within one hour of attack onset to be most effective, STOP 301 reported TRUDHESA offered consistent efficacy even when taken late into a migraine attack.

“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 Chief Executive Officer of Impel NeuroPharma. “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.”