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

I-Corps项目更广泛的影响/商业潜力是提供一种安全有效的非阿片类药物治疗，以控制术后疼痛，从而消除手术后对处方阿片类药物的需求。手术是患者发生或恶化阿片类药物滥用障碍风险的关键点。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翻了两番。处方阿片类药物是成瘾和不良事件的主要驱动因素。目前外科手术后非阿片类药物局部控制疼痛的选择有限。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780亿美元的损失。每年有超过14000人死于处方阿片类药物滥用。随着每年手术数量的增加，以及门诊手术变得越来越普遍，改善对术后疼痛的控制可以对不断上升的医疗保健成本产生重大且越来越大的影响。这个I-Corps项目寻求进一步发展一种新的长时间局部麻醉配方来控制术后疼痛。拟议的创新将是现成的，即用型的，并且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批准的局部麻醉药物布比卡因的延长释放。体外释药试验发现，该创新技术可使布比卡因持续释放数天。与两个临床标准对照组相比，拟议的创新提供了更大水平的麻醉（更大的爪子戒断潜伏期），持续时间更长。与目前的手术疼痛局部治疗方案相比，该创新方案可能具有显著的临床优势，如更强的麻醉/镇痛效果、持续时间和新颖直观的给药途径。通过提供安全有效的非阿片类药物治疗急性术后疼痛，该制剂有可能消除术后对处方阿片类药物的需求。该奖项反映了美国国家科学基金会的法定使命，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.