Impel NeuroPharma to Present New Data on INP104 for Treatment of Acute Migraine at 2018 Annual American Headache Society Meeting
posted in Press Releases by Marjorie Diddams
SEATTLE, June 26, 2018 — Impel NeuroPharma, a Seattle-based, privately-held biotechnology company focused on therapies for the treatment of central nervous system (CNS) disorders, today announced new data from the Company’s investigational drug INP104 for acute migraine will be presented at the American Headache Society’s 60th Annual Meeting, June 28 – July 1, 2018.
These data reinforce the growing body of data from the development of INP104, a drug-device combination product comprised of intranasal dihydroergotamine (DHE) using Impel’s novel Precision Olfactory Delivery, or POD®, to deliver DHE to the upper nasal cavity, offering rapid and optimized bioavailability without injection.
“We look forward to sharing these new INP104 data with the migraine treatment community, who have long recognized the established safety and efficacy of DHE to treat migraines, but have sought more optimal delivery solutions,” said Steve Shrewsbury, M.D., Chief Medical Officer of Impel NeuroPharma. “INP104 will enter a pivotal safety trial in the second half of 2018 and upon successful completion be ready for FDA submission in late 2019.”
Earlier this month, Impel received approval by the U.S. Food and Drug Administration (FDA) for the Company’s submission of an Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial evaluating the safety and tolerability of long-term, intermittent use of INP104 for the treatment of acute migraine headache. The Company expects to commence enrollment in H2 2018.
The poster will be displayed from 7:00 p.m. PTD on Thursday, June 28th to 5:00 p.m. PDT on Friday, June 29th:
- [#PF45] Safety, Tolerability and Comparative Bioavailability of a Novel Intranasal DHE Product (INP104), Friday June 29th, Yerba Buena Ballroom, San Francisco Marriott Marquis
- Question and Answer Session with Dr. Shrewsbury, 1:15 – 2:15 p.m. PDT
- E-poster presentation, San Francisco Marriott Marquis, Room 1, 1:55 – 2:00 p.m. PDT
INP104 is a drug-device combination product being studied for acute migraine headache. It is comprised of an intranasal formulation of dihydroergotamine (DHE) and Impel’s novel Precision Olfactory Delivery, or POD, device. The POD is a novel, simple-to-use device designed to deliver consistent and predictable doses of drug. INP104, an investigational new drug, delivers DHE to the richly vascularized upper nasal cavity, offering rapid and optimized bioavailability without injection. DHE is an established and highly-effective treatment option for acute migraine treatment.
About Acute Migraine
Migraine is a common and debilitating neurological disease characterized by recurrent episodes of severe head pain and associated with nausea, vomiting, sensitivity to light and to sound. Migraine affects more than 36 million people in the United States and over 90% of these have acute migraines averaging less than four migraines per month. The majority of people that suffer from acute migraines are either untreated or dissatisfied with currently-available treatments. They are seeking treatments that offer rapid and durable control of their pain.
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