Impel NeuroPharma, Inc. announced that it will present data from eight scientific abstracts at the 63rd American Headache Society Annual Scientific Meeting (AHS), taking place virtually from June 3 to 6, 2021. Investigational INP104 is dihydroergotamine mesylate (DHE) delivered directly into the vascular-rich upper nasal space using Impel’s proprietary Precision Olfactory Delivery (POD) technology. Many current nasal delivery technologies sprays, droppers, and pumps may deliver less than 5% of the active drug to the upper nasal space. Impel will share data from its pivotal Phase 3, open-label 'STOP-301' study evaluating INP104 for the acute treatment of migraine, including patient-reported exploratory efficacy findings for pain and most bothersome symptom relief and freedom regarding consistency and sustainability of response and migraine recurrence. STOP-301 safety and tolerability data presentations will include findings on nausea, as well as nasal and cardiovascular safety. STOP-301 is a Phase 3, pivotal, open-label trial evaluating the safety, tolerability, and exploratory efficacy of INP104. Additionally, Impel will present a literature review regarding DHE pharmacology and DHE’s broad receptor profile. The New Drug Application (NDA) for INP104 was accepted for review by the U.S. Food and Drug Administration (FDA) in January 2021 and has a Prescription Drug User Fee Act (PDUFA) target action date of September 6, 2021. If approved by the FDA, INP104 will become the first and only therapy to deliver DHE to the vascular-rich upper nasal space using the POD technology, a novel delivery system. The FDA has conditionally accepted a trade name of TRUDHESA. About STOP-301: STOP-301 was a pivotal, Phase 3 open-label study that evaluated the safety, tolerability, and exploratory efficacy of INP104. The trial enrolled 360 patients at 36 sites in the United States who had a documented diagnosis of migraine with or without aura, with at least two attacks per month for the previous six months. The study evaluated 6,332 doses of INP104. In the trial, 354 patients received at least one dose of INP104 and comprised the 24-week Full Safety Set. Of the 185 patients who took an average of two or more treatments with INP104 per 28-day period during the 24-week treatment period comprised the Primary Safety Set. Of those enrolled, 74% (n=262) of patients completed the 24-week treatment period. A subset of 73 patients continued into a 28- week treatment extension period to 52 weeks total, of which 90% completed.