Development of an intranasal, direct to nerve treatment for headache disorders

开发鼻内、直接神经治疗头痛疾病

基本信息

  • 批准号:
    10382876
  • 负责人:
  • 金额:
    $ 33.69万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-08-19 至 2024-07-31
  • 项目状态:
    已结题

项目摘要

PROJECT SUMMARY According to the US Centers for Disease Control, 14.2% of US adults report experiencing migraine symptoms within any given 3-month period, making it the second most disabling illness in the world. Diagnosed migraine is typically categorized as either episodic (2 – 14 days per month) or chronic (15 or more days per month), with each attack accompanied by a combination of debilitating pain and symptoms that persist between 4 - 72 hours. There is no absolute cure for migraine, and the overall financial burden associated with these disorders is more than $72B annually in the US and Europe. For individuals affected, however, the personal “costs” go well beyond financial and physical pain and are reflected in decreased relationship satisfaction, increased dependency on caregivers, and loss of work and social productivity. Despite increased recognition of parasympathetic activation of the trigeminovascular system through the SPG, the majority of acute migraine therapies target downstream effects of trigeminovascular activation, including CGRP receptors and 5-HT receptors. Nonspecific pain medications used in migraine (acetaminophen, NSAIDs, opioids) may have a more direct anti- nociceptive effect on the trigeminovascular system, but they either lack adequate potency for severe migraine symptoms or cause significant adverse effects. Sphenopalatine ganglion (SPG) block procedures directly target the trigeminal nerve and have been identified as an effective, in-clinic method for reducing migraine symptoms that can be administered as often as needed without the potential for severe or addictive side effects. To date, these procedures have not been considered a strong alternative to front-line medications due to their 1) Necessity for administration by a trained healthcare professional, 2) Difficult and uncomfortable route of administration, and 3) High supply and procedural costs compared to single-dose medication. In response to the increasing clinical need for alternative migraine therapies, our team comprised of migraine care specialists, device and drug developers, and clinical research specialists has created a technology for accurately delivering medication to the upper-posterior nasal cavity, enabling development of a self- administered SPG block combination product that provides rapid pain relief without the harsh and addictive side effects of existing medications. The Principal Objectives of this Phase I SBIR, separated into two distinct Aims, are to establish technical efficacy and evaluate commercial design feasibility for self-administration – a critical component for treatment efficacy. In the first aim, components affecting nasal spray characteristics will be designed and prototyped. Benchtop and in vitro performance testing will be conducted using a surrogate nasal cast and laser diffraction techniques to measure and optimize droplet size, distribution patterns, drug substance delivery rate, total drug substance delivered, and nasal cavity deposition to ensure local drug application to the SPG while meeting specifications for function and safety based on current recommendations for drug delivery devices. Aim 2 will focus on the creation of system-level designs for the delivery device through formative human factors evaluations that will bring together diverse groups of migraine patients, clinical care professionals, and key opinion leaders. The conclusion of Aim 2 will be an FDA pre-IND meeting to obtain clarification on the regulatory pathway and preclinical and clinical testing to support a successful NDA application.
项目摘要 根据美国疾病控制中心的数据,14.2%的美国成年人报告在任何时间内都有偏头痛症状。 在三个月的时间里,它是世界上第二大致残性疾病。诊断的偏头痛通常被归类为 发作期(每月2 - 14天)或慢性(每月15天或以上),每次发作伴有 使人衰弱的疼痛和症状的组合持续4 - 72小时。偏头痛没有绝对的治愈方法, 在美国和欧洲,与这些疾病相关的总体经济负担每年超过720亿美元。为 然而,受影响的个人的“成本”远远超出了经济和身体上的痛苦,并反映在 关系满意度下降,对照顾者的依赖增加,以及工作和社会生产力的损失。尽管 通过SPG增加对三叉神经血管系统的副交感神经激活的识别,大多数 急性偏头痛治疗靶向三叉神经血管激活的下游效应,包括CGRP受体和5-HT 受体。用于偏头痛的非特异性止痛药(对乙酰氨基酚,NSAID,阿片类药物)可能具有更直接的抗- 对三叉神经血管系统的伤害性作用,但它们对严重的偏头痛症状缺乏足够的效力 或造成严重的不良影响。蝶腭神经节(SPG)阻滞手术直接靶向三叉神经 并已被确定为减轻偏头痛症状的有效临床方法,可作为 通常根据需要而没有严重或成瘾性副作用的可能性。到目前为止,这些程序尚未 被认为是一线药物的强有力的替代品,因为它们1)需要由受过训练的 医疗保健专业人员,2)给药途径困难和不舒服,以及3)供应和程序成本高 与单剂量药物相比。为了应对日益增加的替代性偏头痛治疗的临床需求,我们的 由偏头痛护理专家、设备和药物开发人员以及临床研究专家组成的团队创建了一个 准确地将药物输送到上后鼻腔的技术,能够开发自 SPG块组合产品,提供快速缓解疼痛,没有苛刻和成瘾的副作用 现有的药物。第一阶段SBIR的主要目标分为两个不同的目标,即建立 自我给药技术功效和评估商业设计可行性--治疗的关键组成部分 功效在第一个目标中,将设计和原型化影响鼻喷雾特性的组件。台式和 将使用替代鼻模型和激光衍射技术进行体外性能测试, 并优化液滴尺寸、分布模式、药物物质递送速率、递送的总药物物质和鼻内给药。 腔沉积,以确保SPG的局部药物应用,同时满足基于功能和安全性的质量标准 关于药物输送装置的当前建议。Aim 2将专注于为 通过形成性人为因素评估,将不同的偏头痛患者群体聚集在一起, 临床护理专业人员和关键意见领袖。目标2的结论将是FDA的IND前会议, 澄清监管途径以及临床前和临床试验,以支持成功的NDA申请。

项目成果

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