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

使用负载布比卡因的聚（酯脲）网进行非阿片类药物术后疼痛管理

基本信息

批准号：
10322523
负责人：
Jiayi Yu
金额：
$ 173.08万
依托单位：
21MEDTECH LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-13 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10322523
关键词：
Absence of pain sensation Acute Acute Pain Address Adhesions Ambulatory Surgical Procedures Amino Acids Animals Bupivacaine Cardiotoxicity Clinical Trials Cyclic GMP Data Development Dose Drug Delivery Systems Drug Kinetics Esters Exposure to Film Formulation Goals Hernia Hour Hydrocodone Implant In Vitro Inflammatory Response Injury Intravenous Kinetics Label Lead Licensing Limb structure Local Anesthetics Medical Device Modeling Monitor Motor Mus Non-Steroidal Anti-Inflammatory Agents Operative Surgical Procedures Opiate Addiction Opioid Oral Orthopedics Oxycodone Pain Pain management Patients Pharmaceutical Preparations Phase Polyesters Polymers Postoperative Pain Postoperative Period Procedures Product Approvals Provider Public Health Recovery Reporting Residual state Risk Safety Site Source Sterilization Surgeon System Therapeutic Thick Time Tissues Toxic effect Trauma United States Urea Work addiction base biodegradable polymer chronic pain management combat commercialization controlled release copolymer diabetic dosage drug efficacy drug release kinetics drug release profile experimental study first-in-human high risk improved in vivo innovation innovative technologies mechanical allodynia mouse model non-opioid analgesic novel strategies operation opioid epidemic opioid overuse opioid policy opioid use opioid use disorder pain model pain relief painful neuropathy prescription opioid repaired safety assessment sciatic nerve soft tissue standard of care stem stoichiometry

项目摘要

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.

概括 21MedTech，LLC正在开发Serenzatm，这是一种非阿片类镇痛药，可从可生物吸收膜发行用于手术后疼痛管理。手术后疼痛管理是造成风险的重要贡献者阿片类药物成瘾和转移。 2018年，美国有近1.29亿个门诊手术，仅骨科医生就占美国所有阿片类药物处方的近8％成瘾和转移很高，目前几乎没有其他选择的阿片类药物来管理后需要手术疼痛和新方法来减少患者接触这些药物并改善正在进行的阿片类药物危机。有几种产品和疗法试图提供非阿片类药物术后缓解疼痛，但尽管有索赔，但这些产品仅用24至48小时，而其他产品则仍然需要其他救援药物。为了满足这种迫切的需求，我们正在开发塞伦扎。塞伦扎是手术后，在手术部位植入局部麻醉的聚合物膜。可调胶片的配方和加载能够控制本地释放，以减轻疼痛的缓解多达四天外科手术。聚合物膜是可生物吸收性的，随着时间的流逝而安全地降解。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体内系统的概念验证。我们的第二阶段目标是为了优化药物释放动力学并制定制造标准，请确定保留率的有效剂量运动功能，并确定小鼠神经性疼痛模型中的安全性和功效。这些完成目标将迈向首次人类临床试验并成功获得FDA批准。成功的塞伦扎的批准和商业化将为提供者减少或手术后，有可能消除阿片类药物的使用和阿片类药物使用障碍的风险。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Application of surface-layer matrix-assisted laser desorption/ionization mass spectrometry imaging to pharmaceutical-loaded poly(ester urea) films.

表层基质辅助激光解吸/电离质谱成像在载药聚（酯脲）薄膜中的应用。

DOI：
10.1016/j.aca.2023.341963
发表时间：
2023
期刊：
Analytica chimica acta
影响因子：
6.2
作者：
Williams-Pavlantos,Kayla;Brigham-Stinson,NatashaC;Becker,MatthewL;Wesdemiotis,Chrys
通讯作者：
Wesdemiotis,Chrys