Analgesic Drug for Local Delivery by Fluoroscopy

透视局部给药镇痛药物

基本信息

批准号：
10166737
负责人：
ANDREAS S. BEUTLER
金额：
$ 158.69万
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 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10166737
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.

根据研究所药品。前3个月，每天有2530万成年人每天疼痛。当前的镇痛疗法通常会因慢性疼痛而失败，并可能导致滥用毒品。 18,893位美国人死于处方阿片类药物 2014年增加了190万。封闭的应用程序开发了非阿片类药物通过荧光镜进行局部递送的镇痛药。荧光镜检查是一种显示X-的医学成像射线图像实时在显示器上，就像一部X射线电影。在荧光镜期间，X射线梁通过通过身体。图像被传输到监视器，以便仪器通过身体运动，例如，可以详细看到注射针。 “介入疼痛”医生是董事会认证专家接受荧光镜训练。 4500个介入疼痛医生在美国练习> 500万每年荧光镜程序。市场研究已经确定了介入性疼痛医生和健康保险经理作为主要客户。拟议的商业产品有潜力迄今为止棘手的慢性局部疼痛的治疗方面的范式转移。提出的研究该第二阶段奖将使商业研发升级到临床阶段。业务机密细节是以特定目的提出。