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Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance Of New Drug Application For INP104 For The Acute Treatment Of Migraine


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SEATTLE, Jan. 20, 2021 /PRNewswire/  Impel NeuroPharma, a late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company s 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults. INP104 is dihydroergotamine mesylate (DHE) delivered directly into the vascular-rich upper nasal space using Impel s proprietary Precision Olfactory Delivery (POD®) technology. If approved, INP104 will be marketed under the trade name, TRUDHESA™, in the U.S. and will become the first and only therapy to utilize the POD technology, a novel delivery system that specifically targets the vascular-rich upper nasal space. ....

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