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Analgesic Drug for Local Delivery by Fluoroscopy

透视局部给药镇痛药物

基本信息

批准号：
10268230
负责人：
ANDREAS S. BEUTLER
金额：
$ 157.22万
依托单位：
INTERVENTIONAL ANALGESIX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10268230
关键词：
Ablation Address Adult Affect American Analgesics Anatomy Animals Arthralgia Autopsy Award Axon Basic Science Binding Blood Blood Chemical Analysis Businesses Chemistry Chili Pepper Chronic Clinic Clinical Clinical Protocols Control Groups Cyclic GMP Cyclodextrins Data Development Diagnostic Diagnostic Procedure Diagnostic radiologic examination Dose Drug abuse Engineering Epidemic FDA approved Facet joint structure Fiber Financial cost Fluoroscopy Formulation Freeze Drying Future Goals Guidelines Health Insurance Heroin High Pressure Liquid Chromatography Human Human Resources Image Injections Institute of Medicine (U.S.)Institutional Review Boards Intervention Investigational Drugs Investments Label Laboratories Lead Leg Market Research Medial Medical Imaging Miniature Swine Modeling Molecular Monitor Motor Movement Names Needles Nerve New Drug Approvals No-Observed-Adverse-Effect Level Nociception Organ Outcome Oxycodone Pain Pain Clinics Pain management Pathology Patients Peripheral Nerves Pharmaceutical Preparations Phase Phase I Clinical Trials Physicians Plant Roots Plants Procedures Public Health Rattus Regimen Reporting Reproducibility Research Resiniferatoxin Roentgen Rays Route Safety Specialist Spinal Canal Spinal nerve structure Synthesis Chemistry TRPV1 gene Testing Therapeutic procedure Time Toxic effect Toxicity Tests Toxicology Toxin Training Validation Vertebral column Vial device X-Ray Computed Tomography analytical method chronic back pain chronic pain clinical examination conventional therapy cost design drug development drug production in vivo instrument local drug delivery meetings movie nerve supply neuropathology non-opioid analgesic novel novel therapeutics pain relief perineural pre-clinical prescription opioid preservation product development programs receptor research and development risk minimization side effect systemic toxicity

项目摘要

Chronic pain affects 116 million Americans at a cost of $560 billion per year according to the Institute of Medicine. 25.3 million adults had pain every day for the preceding 3 months. Current analgesic therapies often fail in chronic pain and can lead to drug abuse. 18,893 Americans died from prescription opioids in 2014, 1.9 million were addicted to them. The enclosed application develops a non- opioid, non-addictive analgesic drug for local delivery by fluoroscopy. Fluoroscopy is a type of medical imaging that shows an X- ray image on a monitor in real time, much like an X-ray movie. During fluoroscopy an X-ray beam is passed through the body. The image is transmitted to a monitor so the movement of an instrument through the body, e.g., an injection needle, can be seen in detail. “Interventional pain” physicians are board certified specialists trained in fluoroscopy. 4500 interventional pain physicians practice in the US performing >5 million fluoroscopic procedures per year. Market research has identified interventional pain physicians and health insurance managers as primary customers. The proposed commercial product has the potential to engender a paradigm-shift in the treatment of hitherto intractable chronic locoregional pain. The studies proposed for this Phase II award will advance commercial R&D to the clinical stage. Business confidential details are presented under Specific Aims.

慢性疼痛影响1.16亿美国人，每年造成5600亿美元的损失医学。在之前的3个月里，有2530万成年人每天都有疼痛。当前的止痛疗法经常在慢性疼痛中失败，并可能导致药物滥用。年有18,893名美国人死于处方阿片类药物 2014年，有190万人对它们上瘾。封闭式应用程序开发了一种非阿片类药物，不会使人上瘾透视下局部给药的止痛药。透视是一种医学成像，它显示X- 在监视器上实时拍摄光线图像，就像X射线电影一样。在透视过程中，X射线束通过穿过身体。图像被传输到监视器，因此器械在身体中的运动，例如注射针，可以详细看到。“介入性疼痛”医生是董事会认证的专家接受过透视方面的培训。4500名介入性疼痛医生在美国执业，执行500；500万每年进行的透视检查。市场研究已经确定了介入性疼痛医生和健康保险经理是主要客户。提议的商业产品有可能产生治疗迄今难以治愈的慢性局部疼痛的范式转变。建议进行的研究这一第二阶段的奖项将把商业研发推进到临床阶段。商业机密详情如下在特定目标下提出。