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Impel NeuroPharma Announces NDA Acceptance of INP104 for Acute Migraine
americanpharmaceuticalreview
January 25, 2021
Impel NeuroPharma announced 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.
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Impel Neuropharma Announces FDA NDA Submission of INP104 for Migraine
americanpharmaceuticalreview
November 19, 2020
Impel NeuroPharma has submitted a New Drug Application (NDA) for INP104 (dihydroergotamine mesylate) or DHE to the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine headaches with or without aura in adult patients.
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Impel NeuroPharma Submits NDA for INP104 in Acute Migraine
contractpharma
November 10, 2020
Impel NeuroPharma has submitted a New Drug Application (NDA) to the U.S. FDA for its lead product candidate, INP104 (dihydroergotamine mesylate, or DHE) for review as a possible new treatment of acute migraine in adult patients.
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Impel NeuroPharma Announces Positive Results from Acute Migraine Treatment Trial
americanpharmaceuticalreview
June 22, 2020
Impel NeuroPharma announced positive results from "STOP 301" (Safety and Tolerability of POD-DHE), the Company's pivotal Phase 3, open-label study of the safety and tolerability of INP104 (dihydroergotamine mesylate) or DHE ...
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Impel NeuroPharma Announces Last Patient Enrolled in INP104 Trial for Migraine
americanpharmaceuticalreview
September 05, 2019
Impel NeuroPharma announced the last patient has been enrolled in "STOP-301" (Safety and Tolerability of POD-DHE), the Company's pivotal open-label Phase 3, multi-use...
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Impel Neuropharma Announces First Patient Dosed In INP104 Trial
americanpharmaceuticalreview
August 27, 2018
Impel NeuroPharma announced the first patient has been dosed in the company's Phase 3, open-label safety and tolerability study evaluating long-term, intermittent use of INP104 for the treatment of migraine headache.