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.

根据美国癌症研究所的数据，慢性疼痛每年影响 1.16 亿美国人，造成 5600 亿美元的损失医学。在过去 3 个月里，每天有 2530 万名成年人感到疼痛。经常对慢性疼痛无效，并可能导致 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。随附的应用程序开发了一种非阿片类药物、不成瘾的药物。通过荧光透视进行局部给药的镇痛药物是一种显示 X 射线的医学成像。监视器上实时显示射线图像，就像 X 射线电影一样。在透视检查过程中，X 射线束通过。通过身体将图像传输到监视器，因此仪器通过身体的运动，例如，注射针，可以详细看到“介入疼痛”医生是委员会认证的专家。 4500 名介入疼痛医师在美国接受过透视检查培训，业绩超过 500 万。每年的荧光镜检查程序已确定介入疼痛医生和健康。拟议的商业产品有潜力产生作为主要客户的保险经理。这些研究提出了治疗迄今为止顽固性慢性局部疼痛的范式转变。该二期合同将推动商业研发进入临床阶段。商业机密详情如下。在具体目标下提出。