Impel NeuroPharma Inc. shares traded to a new 52-week high after the company reported the US Food and Drug Administration told TRUDHESA ?? (Dihydroergotamine Mesylate), a patient-friendly nasal spray that provides rapid relief and treatment of acute migraines.
Commercial biopharmaceutical company Impel NeuroPharma Inc. (IMPL: NASDAQ), which focuses on developing transformative therapies for people with central nervous system (CNS) disorders, announced today that “the US Food and Drug Administration (FDA) TRUDHESA ™. Has approved “. (Dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraines with or without aura in adults. “
The report showed that TRUDHESA, using Impel NeuroPharma’s proprietary Precision Olfactory Delivery (POD®) technology, is able to rapidly deliver dihydroergotamine mesylate (DHE) directly into the bloodstream through the vascularized upper nasal cavity. In doing so, the company stated that TRUDHESA provides quick, sustained, and consistent symptom relief without injection or infusion by bypassing the stomach and related issues that inhibit absorption. The company said TRUDHESA is effective even if given several hours after a migraine occurs.
The company announced that TRUDHESA will be commercially available early next month for the treatment of adults with active migraines, with or without aura.
Adrian Adams, Chairman and CEO of Impel NeuroPharma, commented, “We are pleased with TRUDHESA’s approval and are proud to offer millions of Americans with migraines an acute non-oral treatment option that provides quick, sustained, and lasting relief, even if only first late in a migraine attack … TRUDHESA’s approval marks the culmination of more than a decade of research and advanced technology to combine the proven effectiveness of DHE with our innovative POD technology. “
The company said its new drug filing (NDA) for TRUDHESA was supported by data gathered in the STOP 301 Phase 3 study, which it believes is “the largest longitudinal study ever conducted of DHE using nasal spray became”. During the STOP 301 study, more than 5,650 migraine attacks were treated over a period of 24 and 52 weeks, respectively.
The primary endpoint of the study was to confirm the safety and tolerability of TRUDHESA and to evaluate the effectiveness of the treatment using questionnaires that were completed by the patients after treatment. The company said the results of the study showed that TRUDHESA provided quick, sustained, and consistent symptom relief.
Stephanie J. Nahas-Geiger, MD, MSEd., Assoc. Prof. in the Department of Neurology and Program Director of the Headache Medicine Fellowship program at Thomas Jefferson University noted, “Many of my patients need more of their migraine treatment, and TRUDHESA offers a non-oral, fast-acting, reliable option that addresses many of the current challenges of medication … Its upper nose administration bypasses the gastrointestinal tract and common migraine phenomena such as nausea and gastroparesis, which can affect the effectiveness of oral treatments, can be taken at any time during a migraine attack so patients need not worry Missing the opportunity to benefit from the application of TRUDHESA within a certain period of time. “
Kevin Lenaburg, Executive Director of the Coalition for Headache and Migraine Patients said, “Migraine is a whole body disease and is the second leading cause of disability… Historically, there have not been enough effective treatments to treat migraine attacks, especially treatments that These are not oral medicines that can be challenging due to the nausea, vomiting, and other gastrointestinal symptoms that can occur during a migraine. We welcome an important new treatment that will enhance the long-established effectiveness of DHE with a non-oral, Innovative delivery system combined This enables patients to self-administer regardless of their location and at any time during a migraine attack. “
The company noted that approximately 31 million adults in the United States have migraines, which are typically characterized by episodes of recurring moderate to severe headache, often accompanied by nausea, sensitivity to light and noise, and vomiting.
The company said “TRUDHESATM (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) is now approved by the US Food and Drug Administration for the acute treatment of migraines with or without aura in adults in the US.”
The company stated that dihydroergotamine mesylate (DHE) was first approved for the treatment of migraines in 1946, has been prescribed for over 70 years, and has been shown to bind successfully to multiple receptors that medical researchers generally believe are associated with the onset and duration of migraines stand .
Impel NeuroPharma is a commercial-stage biopharmaceutical company headquartered in Seattle, Wash., Engaged in developing transformative therapies with optimal delivery modes for those with central nervous system disorders and other high unmet medical needs. The company stated that “it offers and develops treatments that combine its proprietary Precision Olfactory Delivery (POD®) technology with established therapeutics.”
The company announced that in addition to its TRUDHESA ™ DHE nasal spray, which has just been approved in the US for the treatment of adult migraines, it is also working on drugs to treat agitation and aggression in autism sufferers and “off” episodes in Parkinson’s disease Cases of illness.
The company believes that the upper nasal cavity, which is surrounded by a rich vasculature, has excellent potential for injection-like absorption, making it a rapid avenue for consistent bioavailability and clinical response. The company found that while this novel method of drug delivery appears to be quite logical and effective, there has not yet been a technology platform that has been proven to deliver therapeutics consistently and safely to the upper nasal area.
Impel NeuroPharma kicked off Friday with a market capitalization of around $ 451.1 million with around 19.51 million shares outstanding and a short stake of around 1.7%. IMPL stock opened today more than 46% higher at $ 33.81 (+ $ 10.69, + 46.24%) above Thursday’s closing price of $ 23.12, quickly hitting a new 52-week price on Friday morning. High of $ 34.75. After trading higher in the morning hours, the stock price fell into negative territory in the early afternoon. The stock traded between $ 16.91 and $ 34.75 per share, closing at $ 18.65 ($ -4.47, -19.93%) on Friday night.
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