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

这个小企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力是一种治疗手术疼痛的新型疗法，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颖、长效的局部麻醉药物产品，作为一种负担得起、安全有效、非阿片类药物的急性疼痛治疗解决方案，可以为客户提供实质性的价值。这项技术可以降低与阿片类药物相关的不良事件相关的医疗成本，并通过手术后不再使用阿片类药物来预防阿片成瘾，从而为医院系统、医生和患者提供重大价值。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造成了724亿美元的损失。通过减少手术患者对阿片类药物的接触来预防阿片成瘾，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4800万例大型外科手术需要术后疼痛管理，代表着170亿美元的潜在美国市场。这个小企业创新研究(SBIR)第二阶段项目旨在执行食品和药物管理局(FDA)所需的制造特征和动物研究，以证明这种新颖的、可注射的长效局部麻醉技术对人类初始使用是安全的。该解决方案涉及一种基于油凝胶的新型注射给药系统，该系统可以提供亲脂性小分子药物的局部持续给药。在第一阶段，该团队对流变性、药物释放动力学和稳定性进行了技术优化，以创造一种可提供96小时持续布比卡因释放的注射凝胶。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.