I-Corps: Injectable extended release local anesthetic for the treatment of post-operative pain

该I-Corps项目的更广泛影响/商业潜力是为控制术后疼痛提供安全有效的非阿片类药物治疗，从而消除术后对处方阿片类药物的需求。手术是一个关键点，患者有发展或恶化阿片类药物滥用疾病的风险。美国和世界各地的阿片类药物危机是一个重大的公共卫生问题。在美国，阿片类药物过量自1999年以来增加了两倍，阿片类药物处方数量增加了四倍。处方阿片类药物是成瘾和不良事件的主要驱动因素。外科手术后疼痛的非阿片样物质局部控制的当前选择是有限的。处方阿片类药物对公共卫生的影响是显著的，10%的患者在手术后继续长期使用，每年给美国医疗保健系统造成780亿美元的成本。每年有超过14，000人死于处方阿片类药物滥用。随着每年进行的手术数量的增加，以及门诊手术变得越来越普遍，改善术后疼痛的控制可以有一个显着的和不断增加的影响不断上升的医疗costs.This I-Corps项目旨在进一步开发一种新的持续时间较长的局部麻醉制剂用于控制术后疼痛。拟议的创新将是现成的，即用型的，并在给药后提供更长时间的安全有效的局部麻醉。它将以可注射的生物可吸收凝胶的形式提供FDA批准的局部麻醉药布比卡因的长期释放。体外药物释放测试发现，该创新可以提供持续多天的布比卡因缓释。与两个临床标准对照组相比，所提出的创新提供了更高水平的麻醉（更大的缩爪时间），持续时间更长。拟议的创新可能会提供显著的临床优势，超过目前的临床选择，局部管理手术疼痛，如更大的麻醉/镇痛效果，效果持续时间，和新的直观的给药途径。该制剂通过提供安全有效的非阿片类药物治疗急性术后疼痛，有可能消除术后对处方阿片类药物的需求。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is to provide a safe and effective non-opioid therapeutic for the control of post-operative pain that could eliminate the need for prescription opioids after surgery. Surgery is a critical point where patients are at risk of developing or worsening opioid-misuse disorders. The opioid crisis in the US and around the world is a significant public health concern. In the US, opioid overdoses have tripled since 1999, with the number of opioid prescriptions quadrupling. Prescription opioids are a major driver of addiction and adverse events. Current options for non-opioid local control of pain after a surgical procedure operation are limited. The public health implications of prescription opioids are significant, with 10% of patients going on to long-term use after surgery, and a cost of $78 billion to the United States health care system annually. Over 14,000 people die of prescription opioid misuse per year. As the number of procedures performed per year increases, and as outpatient surgery becomes more prevalent, improving control of post-operative pain can have a significant and increasing impact on rising health-care costs.This I-Corps project seeks to further develop a novel prolonged duration local anesthetic formulation for control of post-operative pain. The proposed innovation would be off-the-shelf, ready-to-use, and provide safe and effective local anesthesia for longer duration after administration. It will be in the form of an injectable bioresorbable gel that provides prolonged release of FDA-approved local anesthetic drug bupivacaine. In vitro drug release testing found that the innovation can provide a sustained release of bupivacaine for multiple days. The proposed innovation provided greater levels of anesthesia (greater paw withdrawal latencies) for a longer duration than both clinical standard control groups. The proposed innovation may provide significant clinical advantages over current clinical options for local management of surgical pain such as greater anesthetic/analgesic effect, duration of effect, and novel intuitive route of administration. This formulation has the potential to eliminate the need for prescription opioids after surgery by providing safe and effective non-opioid management of acute postoperative pain.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.