SBIR Phase II: Novel, injectable, long-acting, local anesthetic for postoperative pain management

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力是一种新的手术疼痛治疗方法，可以消除手术后对阿片类药物的需求。该项目将产生一种新型的长效局部麻醉药物产品，作为一种价格合理、安全有效、非阿片类药物的急性疼痛管理解决方案，为客户提供可观的价值。该技术可以降低与阿片类药物相关不良事件相关的医疗成本，并通过消除手术后阿片类药物的使用来预防阿片类药物成瘾，从而为医院系统、医生和患者提供重要价值。2021年，阿片类药物过量死亡人数出现历史性上升，超过8万人。在过去的15年里，与阿片类药物使用障碍相关的医疗补助支出增加了两倍多，在此期间，阿片类药物危机估计耗资724亿美元。通过减少手术患者接触阿片类药物来预防阿片类药物成瘾，可以对降低整个社会的经济成本产生重大影响。2017年，美国估计有4800万例重大外科手术需要术后疼痛管理，这代表了170亿美元的美国潜在市场。这项小型企业创新研究（SBIR）二期项目旨在执行美国食品和药物管理局（FDA）要求的制造特性和动物研究，以证明这种新型的、可注射的、长效局部麻醉技术对最初的人类使用是安全的。该解决方案涉及一种新型的基于油凝胶的可注射药物递送系统，该系统可以提供局部持续的亲脂性小分子药物递送。在第一阶段，该团队优化了该技术的流变特性、药物释放动力学和稳定性，创造了一种可注射的凝胶，可持续递送96小时的布比卡因。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 Small Business Innovation Research (SBIR) Phase II project is a novel therapeutic for surgical pain that can eliminate the need for opioids after surgery. This project will yield a novel, long-acting local anesthetic drug product that can provide substantial value to customers as an affordable, safe, and effective, non-opioid, acute pain management solution. The technology can provide significant value to hospital systems, physicians, and patients alike by reducing healthcare costs associated with opioid-related adverse events and preventing opioid addiction by eliminating their use after surgery. In 2021, there was a historic rise in opioid overdose deaths to over 80,000 individuals. Opioid use disorder-related Medicaid spending has more than tripled in the last 15 years and the opioid crisis has been estimated to cost $72.4 billion during that time period. Preventing opioid addiction by reducing exposure of opioids to surgical patients can have a significant impact on reducing financial costs to society as a whole. In 2017, there were an estimated 48 million major surgical procedures requiring postoperative pain management in the United States, representing a $17 billion total addressable US market.This Small Business Innovation Research (SBIR) Phase II project seeks to perform Food and Drug Administration (FDA) required manufacturing characterization and animal studies to demonstrate the novel, injectable, long-acting local anesthetic technology is safe for initial human use. The solution involves a novel oleogel-based injectable drug delivery system that can provide local sustained delivery of lipophilic small molecule drugs. In Phase I, the team optimized the technology for rheological properties, drug release kinetics, and stability to create an injectable gel that provides 96 hours of sustained bupivacaine delivery.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.