Impel NeuroPharm生物技術(shù)公司于2021年9月3日宣布美國FDA批準(zhǔn)TRUDHESA?（甲磺酸二氫Ergotamine）鼻噴霧劑用于偏頭痛的急性治療。

    實(shí)驗(yàn)數(shù)據(jù)表明TRUDHESA?相比甲磺酸二氫Ergotamine口服制劑對(duì)于偏頭痛的急性治療具有更好的耐受性和快速、持續(xù)和一致的癥狀緩解功效，并且副作用比例和癥狀遠(yuǎn)遠(yuǎn)小于口服制劑，詳情請(qǐng)見以下網(wǎng)站原文鏈接和摘要。

https://investors.impelnp.com/news-releases/news-release-details/impel-neuropharma-announces-us-fda-approval-trudhesatm

Impel NeuroPharma Announces U.S. FDA Approval of TRUDHESA? (Dihydroergotamine Mesylate) Nasal Spray for the Acute Treatment of Migraine

Sep 03, 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 TRUDHESA? (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in *****s. TRUDHESA was previously known as INP104.

Using Impel’s proprietary Precision Olfactory Delivery (POD®) technology, TRUDHESA gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich upper nasal space.1 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.”

TRUDHESA will be available through Trudhesa? Direct, a hassle-free pharmacy partnership and copay program. The digital pharmacy fulfilment partners, Phil Inc. and Carepoint Pharmacy, will provide electronic prescribing and automatic enrollment in the patient savings program for eligible, commercially insured patients without the need for a paper copay card. The pharmacy partners will provide a customized and seamless patient experience. Once the pharmacy receives the e-prescription, patients will be notified via digital communications that their prescription has been processed and receive their medication via convenient, free, home delivery. For more information, please visit, www.TRUDHESA.com.