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

• 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
• 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

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.

总结

项目成果

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