Commercial-stage biopharmaceutical company Impel NeuroPharma Inc. (IMPL:NASDAQ), which is focused on developing transformative therapies for people afflicted with central nervous system (CNS) disorders, today announced that "the U.S. Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults."
The report indicated that using Impel NeuroPharma 's proprietary Precision Olfactory Delivery (POD®) technology, TRUDHESA is able to quickly deliver dihydroergotamine mesylate (DHE) directly to the bloodstream through the vascular-rich upper nasal space. By doing so, the company stated that TRUDHESA offers rapid, sustained and consistent symptom relief without injection or infusion by bypassing the stomach and related issues that inhibit absorption. The firm advised that TRUDHESA is effective even when administered several hours after onset of a migraine occurrence.
The company advised that TRUDHESA is schedule to be launched commercially early next month for use in treating adults experiencing active migraine headaches, with or without aura.
Impel NeuroPharma's Chairman and CEO Adrian Adams commented, "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…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."
The company said that its New Drug Application (NDA) for TRUDHESA was supported from data gathered in the Phase 3 STOP 301 trial, which it noted is "the largest longitudinal study ever conducted with DHE using nasal spray delivery." During the STOP 301 study, greater than 5,650 migraine attacks were treated over a period of 24 or 52 weeks.
The study's primary endpoint was to confirm the safety and tolerability of TRUDHESA and to assess the efficacy of treatment as measured from questionnaires completed by patients following treatment. The firm said the results in the study demonstrated that TRUDHESA provided rapid, sustained, and consistent symptom relief.
Stephanie J. Nahas-Geiger, M.D., MSEd., Assoc. Prof. in the Dept. of Neurology and Program Director of the Headache Medicine Fellowship Program, Thomas Jefferson University, remarked "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…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."
Executive Director Kevin Lenaburg of the Coalition for Headache and Migraine Patients, stated, "Migraine is a disease that impacts the whole body and is the second leading cause of disability…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 GI 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."
The company pointed out that around 31 million adults in the U.S. experience migraines, which are typically characterized by episodes of recurring moderate to severe head pain that is frequently associated with nausea, sensitivity to light and sound, and vomiting.
The company listed that "TRUDHESATM (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) is now approved by the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults in the U.S."
The firm explained that dihydroergotamine mesylate (DHE) was first approved for migraine treatment in 1946 and has been prescribed for over 70 years and has been proven to successfully bind to multiple receptors that are commonly believed by medical researchers to be implicated in migraine onset and duration.
Impel NeuroPharma is a commercial-stage biopharmaceutical firm headquartered in Seattle, Wash. that is engaged in developing transformative therapies with optimal delivery methods for individuals suffering from central nervous system diseases and other high unmet medical needs. The company stated that "it offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics."
The firm advised that in addition to its TRUDHESA™ DHE nasal spray that was just approved in the U.S. for use in treating migraines in adults, it is also presently working on medicines for treating agitation and aggression in autism patients and "off" episodes in Parkinson's disease cases.
The company believes that the upper nasal space, which is surrounded by a rich vasculature, shows excellent potential for injection-like absorption and thus presents a rapid pathway for consistent bioavailability and clinical response. The firm noted that though this novel method of drug delivery appears to be quite logical and effective, so far there has not been any technology platform that has been proven to be capable of consistently delivering therapeutics consistently and safely to the upper nasal area.
Impel NeuroPharma started Friday with a market cap of around $451.1 million with approximately 19.51 million shares outstanding and a short interest of about 1.7%. IMPL shares opened more than 46% higher today at $33.81 (+$10.69, +46.24%) over Thursday's $23.12 closing price and quickly reached a new 52-week high price Friday morning of $34.75. After trading higher in the morning hours, the share price dropped into negative territory in the early afternoon. The stock traded between $16.91 to $34.75 per share and closed at $18.65 (-$4.47, -19.93%) Friday evening.
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