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Impel NEUROPHARMA Impel NeuroPharma Announces U.S. FDA Approval of TRUDHESATM ( Dihydroergotamine Mesylate ) Nasal Spray for the Acute Treatment of Migraine September 3 , 2021 TRUDHESA Is the First and Only Therapeutic to Use POD technology to Deliver Dihydroergotamine Mesylate ( DHE ) to the Vascular - Rich Upper Nasal Space TRUDHESA Is Well Tolerated and Delivers Rapid , Sustained and Consistent Symptom Relief for the Acute Treatment of Migraine Commercial Launch of TRUDHESA is Planned for Early October 2021 Impel to Host Investor Call on Tuesday , September 7 , 2021 at 8:30 a.m. ET SEATTLE , Sept. 03 , 2021 ( GLOBE NEWSWIRE ) Impel NeuroPharma , Inc. ( NASDAQ : IMPL ) , a commercial - stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs , with an initial focus on the central nervous system , today announced that the U.S. Food and Drug Administration ( FDA ) approved TRUDHESATM ( 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 INP 104 . Using Impel's proprietary Precision Olfactory Delivery ( PODⓇ ) technology , TRUDHESA gently delivers dihydroergotamine mesylate HE ) -a proven , well - established therapeutic - quickly to the bloodstream through the vascular - rich upper nasal space ! TRUDHESA bypasses the gut and potential absorption issues , offering rapid , sustained , and consistent symptom relief without injection or infusion , even when administered hours after the onset of a migraine attack.2 The Commercial launch of TRUDHESA is planned for early October 2021 . " 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 . " The New Drug Application for TRUDHESA included the results of the Phase 3 , open - label , pivotal safety study , STOP 301 , which is the largest longitudinal study ever conducted with DHE using nasal spray delivery.³ More than 5,650 migraine attacks were treated over 24 or 52 weeks during the study . The primary objective of the study was to assess the safety and tolerability of TRUDHESA . Exploratory objectives included efficacy assessments of migraine measures and a patient acceptability questionnaire . 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.4 " Many of my patients need more from their migraine treatment , and TRUDHESA offers a non - oral , fast - acting , reliable option that overcomes many current medication challenges , " said Stephanie J. Nahas - Geiger , MD , MSEd , Associate Professor in the Department of Neurology , and Program Director of the Headache Medicine Fellowship Program , Thomas Jefferson University . " Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine , such as nausea and gastroparesis , that can impact the effectiveness of oral treatments . And , importantly , it is a self - administered , single dose that can be taken anytime during a migraine attack , so patients don't need to worry about missing the opportunity to benefit from using TRUDHESA within a certain timeframe . I think patients will be very receptive to this treatment , because it pairs the long - proven benefits of DHE with a patient - friendly delivery system . " There were no serious TRUDHESA - related treatment - emergent adverse events ( TEAES ) observed in the STOP 301 study and the majority of TEAES were mild and transient in nature.4 Some of the most frequently reported TRUDHESA - related TEAES ( 22 % ) during the entire 52 - week study period were nasal congestion ( 17.8 % ) , nausea ( 6.8 % ) , nasal discomfort ( 6.8 % ) , abnormal olfactory test ( 6.8 % ) and vomiting ( 2.7 % ) . 5 In the STOP 301 study , patient - reported exploratory efficacy findings reported that more than a third of patients ( 38 % ) had pain freedom , 6 two - thirds ( 66 % ) had pain relief , 7 and more than half ( 52 % ) had freedom from their most bothersome migraine symptom8 at two hours after their first dose of TRUDHESA . For one in six patients ( 16 % ) , pain relief started as early as 15 minutes . Of patients who were pain free at two hours , 93 percent were still pain free at 24 hours , 11 and 86 percent were still pain free through two days . The great majority of patients ( 84 % ) reported that TRUDHESA was easy to use ¹0 and preferred it over their current therapy.1 11 " Migraine is a disease that impacts the whole body and is the second leading cause of disability , " 12 said Kevin Lenaburg , executive director , Coalition for Headache and Migraine Patients ( CHAMP ) , which represents 12 national headache and migraine patient advocacy groups . " Historically there have not been enough effective treatments for treating migraine attacks , especially treatments that are not oral medicines , which can be challenging due to nausea , vomiting and other Gl symptoms that can occur during a migraine . We welcome an important new treatment that combines the long - established efficacy of DHE with a non - oral , innovative delivery system that allows patients to self - administer wherever they are and at any point within a migraine attack . "