Impel
NeuroPharm生物技术公司于2021年9月3日宣布美国FDA批准TRUDHESA™（甲磺酸二氢Ergotamine）鼻喷雾剂用于偏头痛的急性治疗。
实验数据表明TRUDHESA™相比甲磺酸二氢Ergotamine口服制剂对于偏头痛的急性治疗具有更好的耐受性和快速、持续和一致的症状缓解功效，并且副作用比例和症状远远小于口服制剂，详情请见以下网站原文链接和摘要。
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.
