Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh

总结 21MedTech，LLC正在开发SERENZATM，一种从生物可吸收薄膜中释放的非阿片类镇痛药 用于术后疼痛管理术后疼痛管理是导致术后疼痛风险的重要因素。 阿片类药物成瘾和转移2018年，美国有近1.29亿例门诊手术， 仅整形外科医生就占美国所有阿片类药物处方的近8%。 成瘾和转移率很高，目前阿片类药物的替代选择很少， 需要手术疼痛和新的方法来减少患者对这些药物的暴露， 阿片类药物危机已经有几种产品和疗法试图提供非阿片类药物 术后疼痛缓解，但这些产品只能工作24至48小时，尽管声称，否则，和其他 仍然需要额外的急救药物。为了满足这一迫切需求，我们正在开发SERENZA。SERENZA是 在手术后植入手术部位的装有局部麻醉剂的聚合物薄膜。可调谐 膜的配制和装载使得能够控制局部释放以缓解疼痛长达四天 手术该聚合物膜是生物可吸收的，并且随着时间的推移安全地降解。我们已经证明了我们的安全 聚合物膜载体，药物的功效，以及我们的系统在体内的概念验证。我们的第二阶段目标是 优化药物释放动力学，制定生产标准，确定保留的有效剂量 的运动功能，并确定在小鼠神经性疼痛模型中的安全性和有效性。完成这些 这些目标将使SERENZA朝着首次人体临床试验和成功获得FDA批准的方向发展。成功 SERENZA的批准和商业化将为供应商提供一个强大的新战略， 可能消除阿片类药物的使用和术后患者阿片类药物使用障碍的风险。

SUMMARY 21MedTech, LLC is developing SERENZATM, a non-opioid analgesic that is released from a bioresorbable film for post-surgical pain management. Post-surgical pain management is a significant contributor to the risk for opioid addiction and diversion. There were nearly 129 million outpatient surgeries in the U.S. in 2018 and orthopedic surgeons alone account for nearly 8% of all opioid prescriptions in the U.S. Though the risk for addiction and diversion is high, there are currently few alternative options to opioids for the management of post- surgical pain and new approaches are needed to reduce patient exposure to these drugs and improve the ongoing opioid crisis. There have been several products and therapies attempting to provide non-opioid postoperative pain relief, but these products only work for 24 to 48 hours, despite claims otherwise, and others still require additional rescue medication. To meet this urgent need, we are developing SERENZA. SERENZA is a polymer film loaded with local anesthetic that is implanted at the surgical site following operation. Tunable formulation of the film and loading enable control over local release for pain relief for up to four days following surgery. The polymer film is bioresorbable and safely degrades over time. We have demonstrated safety of our polymer film carrier, efficacy of the drug, and proof-of-concept of our system in vivo. Our Phase II objectives are to optimize drug release kinetics and develop manufacturing standards, determine effective dosage for retention of motor function, and determine safety and efficacy in mouse neuropathic pain models. Completion of these goals will progress SERENZA toward first in-human clinical trials and successful FDA approval. Successful approval and commercialization of SERENZA will enable a powerful new strategy for providers to reduce or potentially eliminate the use of opioids and the risk of opioid use disorder for patients following surgery.