ICORPS: User-centric development of closed-loop therapy for opioid overdose

ICORPS：以用户为中心开发阿片类药物过量闭环疗法

• 批准号: 10742328
• 负责人: Hyowon Lee
• 金额: $ 5.5万
• 依托单位: RESCUE BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-06 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10742328
• 关键词: Accidents; Antidotes; Awareness; COVID-19 pandemic; Caring; Cessation of life; Development; Devices; Drug Addiction; Drug Delivery Systems; Ensure; Feedback; Harm Reduction; Implant; Indiana; Licensing; Life; Medical; Morphine; Naloxone; Opioid; Overdose; Patients; Pharmaceutical Preparations; Phase; Professional counselor; Recommendation; Respiratory Failure; Self Administration; Small Business Innovation Research Grant; Social isolation; Symptoms; System; Time; Universities; Work; capsule; cohort; combat; commercialization; cost; design; design verification; experimental study; implantable device; medical schools; minimally invasive; novel; opioid mortality; opioid overdose; opioid therapy; pre-clinical; prevent; subcutaneous; synthetic opioid; tool; usability; wearable device; willingness

Project Summary/Abstract This Fast-Track SBIR proposal will help make significant inroads towards commercializing Rescue Biomedical LLC's automatic antidote delivery device (A2D2) in order to combat opioid overdose-related deaths. Despite increasing awareness of the dangers associated with opioids, there were more than 70,000 deaths due to opioid overdose in 2020. In addition, the rising popularity of illegal synthetic opioids and social isolation due to the ongoing COVID-19 pandemic is fueling a third wave of opioid-related deaths. Since these illegal drugs are orders of magnitude more potent than morphine and can cause respiratory failure in minutes, there is very little time for users to identify and respond to the symptoms of overdose with antidotes like naloxone. The proposed A2D2 is a low-cost and simple subcutaneous drug delivery capsule that can automatically detect opioid- induced respiratory failure and release naloxone in a closed-loop manner. It will extend the lifetime of overdosed patients so that they can receive proper medical care. In this Fast-Track SBIR proposal, Rescue Biomedical seeks to validate its hypothesis that there is a significant demand for a wearable-implantable combinational device for automatically detecting and treating opioid overdose. In Phase I, Rescue Biomedical will work with its collaborator at Indiana University School of Medicine to quantify users' willingness to use wearable and implantable devices. Furthermore, clinicians and other stakeholders (e.g., Licensed Chemical Dependency Counselor) will be identified to understand their willingness to recommend advanced harm reduction devices. Finally, Rescue Biomedical will leverage the cohort of these stakeholders to validate the overall system design to ensure high compliance and usability. In Phase II, efforts will be focused on technical integration and performing a pivotal pre-clinical experiment to demonstrate the closed-loop capabilities to reverse the effects of opioid overdose. Moreover, Rescue Biomedical will focus efforts for commercialization including regulatory submissions for IND/IDE submission and performing design verification and validation based on user feedback.

项目总结/摘要 这一快速通道SBIR提案将有助于在Rescue Biomedical商业化方面取得重大进展 LLC的自动解毒剂输送装置（A2 D2），以打击阿片类药物过量相关的死亡。尽管 随着人们对阿片类药物相关危险的认识不断提高， 2020年的鸦片战争此外，非法合成阿片类药物的日益流行和社会孤立， 持续的COVID-19大流行正在引发第三波阿片类药物相关死亡。由于这些非法药物 比吗啡强几个数量级，能在几分钟内引起呼吸衰竭， 用户有时间识别和应对纳洛酮等解毒剂过量的症状。拟议 A2 D2是一种低成本和简单的皮下给药胶囊，可以自动检测阿片类药物， 诱导呼吸衰竭并以闭环方式释放纳洛酮。它将延长 过量用药的病人，以便他们能够得到适当的医疗照顾。 在这个快速通道SBIR提案中，Rescue Biomedical试图验证其假设，即存在一个显著的 对用于自动检测和治疗阿片样物质的可穿戴-可植入组合装置的需求 服药过量在第一阶段，Rescue Biomedical将与印第安纳州大学医学院的合作者合作， 医学量化用户使用可穿戴和植入式设备的意愿。此外，临床医生和 其他利益相关者（例如，持牌化学品部顾问），以了解他们的 愿意推荐先进的减害设备。最后，Rescue Biomedical将利用 这些利益相关者的队列，以验证整体系统设计，以确保高合规性和可用性。在 第二阶段的工作重点是技术整合和进行关键的临床前实验， 证明了逆转阿片类药物过量影响的闭环能力。此外，救援 Biomedical将专注于商业化工作，包括IND/IDE申报的监管申报 以及基于用户反馈执行设计验证和确认。