11.09.20
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. INP104 uses the Company’s proprietary Precision Olfactory Delivery (POD) technology – a novel delivery system that is the first to target the vascular-rich upper nasal space as a viable treatment pathway.
Impel is focused on the development and commercialization of transformative therapies for patients living with central nervous system (CNS) disorders with high unmet medical needs and INP104 is the Company’s first therapeutic candidate to be submitted for U.S. regulatory review.
INP104 utilizes Impel’s propellant-enabled POD system to conveniently and consistently deliver optimal doses of DHE deep into the vascular rich upper nasal space, an ideal target for efficient drug administration, particularly for the majority of patients with migraine who experience nausea and/or vomiting during an attack, which presents limitations for the use of oral therapies, including triptans, CGRP inhibitors and ditans as well as other non-specific acute migraine medications.
The NDA submission for INP104 is supported by safety results from the pivotal Phase 3 STOP 301 study, in which over 5,650 migraine attacks were treated over 24 or 52 weeks. The study met its primary objectives. Exploratory efficacy data observed that 66.3% of patients reported pain relief, 38% of patients reported pain freedom, and 52% had freedom from their most bothersome migraine symptom (MBS) at two hours following their first dose of INP104. In 85% of reported migraine attacks, patients did not require rescue medication. Initial onset of pain relief as early as 15 minutes was reported by 16.3% of patients, which continued to improve over time.
Impel is focused on the development and commercialization of transformative therapies for patients living with central nervous system (CNS) disorders with high unmet medical needs and INP104 is the Company’s first therapeutic candidate to be submitted for U.S. regulatory review.
INP104 utilizes Impel’s propellant-enabled POD system to conveniently and consistently deliver optimal doses of DHE deep into the vascular rich upper nasal space, an ideal target for efficient drug administration, particularly for the majority of patients with migraine who experience nausea and/or vomiting during an attack, which presents limitations for the use of oral therapies, including triptans, CGRP inhibitors and ditans as well as other non-specific acute migraine medications.
The NDA submission for INP104 is supported by safety results from the pivotal Phase 3 STOP 301 study, in which over 5,650 migraine attacks were treated over 24 or 52 weeks. The study met its primary objectives. Exploratory efficacy data observed that 66.3% of patients reported pain relief, 38% of patients reported pain freedom, and 52% had freedom from their most bothersome migraine symptom (MBS) at two hours following their first dose of INP104. In 85% of reported migraine attacks, patients did not require rescue medication. Initial onset of pain relief as early as 15 minutes was reported by 16.3% of patients, which continued to improve over time.
