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INP104:一种非口服产品治疗偏头痛急性发作的药物评价。

INP104: a drug evaluation of a nonoral product for the acute treatment of migraine.

机构信息

Department of Neurology, Mayo Clinic, Scottsdale, AZ 85259, USA.

Stanford Health Care, Division of Pain Medicine, Redwood City, CA 94063, USA.

出版信息

Pain Manag. 2023 May;13(5):283-298. doi: 10.2217/pmt-2022-0063. Epub 2023 Jun 20.

DOI:10.2217/pmt-2022-0063
PMID:37337861
Abstract

Migraine is a highly prevalent, disabling neurological disorder that is also associated with gastrointestinal symptoms, autonomic dysfunction and allodynia. Despite the availability of multiple acute agents for migraine, an unmet need remains for effective, well-tolerated drugs that are nonoral and noninvasive. Here, we provide a drug evaluation of INP104, a novel drug-device combination product of dihydroergotamine (DHE) mesylate - a molecule with a long history of efficacy familiar to headache specialists - which is delivered to the difficult-to-reach upper nasal space where it is rapidly and consistently absorbed Precision Olfactory Delivery (POD). In clinical trials, INP104 exhibited favorable pharmacokinetics, a well-tolerated safety profile, and rapid symptom relief, highlighting its potential as a suitable acute therapy for migraine.

摘要

偏头痛是一种普遍存在且致残性的神经系统疾病,常伴有胃肠道症状、自主神经功能障碍和痛觉过敏。尽管有多种急性偏头痛治疗药物,但仍需要有效的、耐受良好的非口服和非侵入性药物。在这里,我们对 INP104 进行了药物评估,这是一种新型的二氢麦角胺(DHE)甲磺酸盐药物-器械组合产品,DHE 甲磺酸盐是一种疗效久经考验的分子,为头痛专家所熟知,通过精密嗅觉输送(POD)递送至难以到达的上鼻道,迅速且持续吸收。在临床试验中,INP104 表现出良好的药代动力学特性、良好的安全性和快速的症状缓解,突出了其作为偏头痛合适急性治疗药物的潜力。

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