INTERVENTIONAL ANALGESIX INC. — Department of Health and Human Services SBIR Phase II: 106

Description

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 andgt;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 Randamp;D to the clinical stage. Business confidential details are presented under Specific Aims.Project Narrative Chronic pain affects 116 million Americans. The total financial costs of this epidemic are andgt;$560 billion. Conventional treatments use a variety of drug regimens but frequently fail to control pain. The development of the proposed new pain-controlling drug is an important goal, because it addresses a public health crisis caused by the effects of opioid medications such as oxycontin. 18,893 Americans died from prescription opioids in 2014 and 1.9 million were addicted to them; 10,574 died from heroin and 586,000 were users, most of whom were first addicted to prescription opioids. Recent studies have demonstrated that chronic pain can be controlled by resiniferatoxin (RTX). The proposed research will develop LPN-CapRTX that will allow us to develop the most viable treatment approach for use in patients with severe, hitherto intractable locoregional pain.