A Rugged, Reliable, Portable, Safe, and Simple Naloxone HCl Auto-Injector forLife-Saving Treatment of Opioid Overdose

坚固、可靠、便携式、安全且简单的盐酸纳洛酮自动注射器，用于挽救阿片类药物过量的生命治疗

• 批准号: 10764158
• 负责人: Conor R Cullinane
• 金额: $ 32.65万
• 依托单位: PIROUETTE MEDICAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10764158
• 关键词: 3D Print; Accidents; Adhesives; Ambulances; Breathing; Clothing; Data; Devices; Dose; Emergency Situation; Epinephrine; Equipment; Failure; Food and Drug Administration Device Approval; Freezing; Future; Goals; Hand; Health Personnel; Hospitalization; Hospitals; Human; Individual; Injections; Injury; Intramuscular; Intuition; Laceration; Length; Life; Marketing; Measures; Medical; Medical Staff; Methods; Modification; Naloxone; Needles; Needlestick Injuries; Opioid; Opioid Antagonist; Overdose; Overdose reversal; Pathway interactions; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Population; Process; Recording of previous events; Safety; Self Administration; Shapes; Stress; Testing; Time; Training; Update; Viscosity; abuse liability; addiction; age group; cost; design; design verification; ergonomics; manufacture; manufacturing process; novel; opioid mortality; opioid overdose; overdose death; portability; prototype; risk minimization; technology platform; usability

Project Summary From 2019 to 2020, overdose deaths in the US increased by 30% year on year; 187 people die each day from opioid overdose in the US. Naloxone has significantly decreased opioid mortality with increased usage as a first line life-saving measure prior to emergency help and hospitalization. Naloxone HCl Injection, USP (Naloxone) is an opioid antagonist that rapidly reverses overdose and quickly restores normal breathing. It can be given to any person showing signs of an overdose. There is no potential for abuse/addiction to Naloxone. The drug is low cost, available across all 50 states, often without a prescription. Ambulances and hospitals have Naloxone on hand, and medical staff trained to administer it; however, a call for help or trip to the ER is often too late. At least 40% of the time, life-saving treatment for opioid overdose is administered by an untrained bystander, often under situations of extreme stress. The benefits of Naloxone for reversing the effects of opioid overdose have been demonstrated conclusively. The most pressing question today then is what method of administration of Naloxone is most efficacious for untrained bystanders. Studies show that Auto-Injectors (AIJ) offer the best combination of low cost, safety, reliability, ergonomic design, and most of all rapid fail-safe injection of Naloxone. Towards this end, Pirouette Medical has developed a novel and proprietary AIJ platform, based on a previous AIJ QUICPUSH for epinephrine injections, that can be adapted to safely deliver intramuscular Naloxone injections correctly and easily. Our Naloxone Auto-Injector (NAIJ), REZQGO, is a low-profile, disk-shaped, injection device with a patient-centric focus on affordability, portability, and usability. Its intuitive design allows individuals with limited or no training to easily administer an injection to themselves or others. The AIJs physical design allows for simple and stress-free self-administration, minimizing the risk of inadvertent administration, lacerations, needle sticks, or other injuries. The device can safely and effectively inject life-saving drugs through various clothing materials. Finally, the REZQGO design is versatile and can be adjusted to accommodate a wide variety of volumes and other parameter changes such as dose delivered and needle injection depth for future drug pairings. In Phase I we will rigorously verify the design and usability of a non-GMP prototype(s) of our REZQGO auto- injector. In Phase II the goal will be to manufacture three GMP registration batches, complete the full set of design validation tests, and submit an NDA to the FDA for regulatory approval via the 505(b)(2) pathway, using QUICPUSH and other commercially available AIJ projects as predicate devices. Overall, this project will help bring to market a novel low-cost device that anyone could use to safely deliver lifesaving Naloxone HCL Injection, USP intramuscularly during an opioid overdose.

项目概要 2019年至2020年，美国服药过量死亡人数同比增长30%；每天有 187 人死于 美国阿片类药物过量。随着纳洛酮作为阿片类药物使用量的增加，可显着降低阿片类药物死亡率 紧急救助和住院之前的一线救生措施。盐酸纳洛酮注射液，USP （纳洛酮）是一种阿片类拮抗剂，可迅速逆转用药过量并迅速恢复正常呼吸。它可以 给予任何有服用过量迹象的人。纳洛酮不存在滥用/成瘾的可能性。 该药物成本低廉，在全美 50 个州均有销售，通常无需处方。救护车和医院 手头有纳洛酮，并有接受过给药培训的医务人员；但是，需要寻求帮助或前往急诊室 往往为时已晚。至少 40% 的情况下，阿片类药物过量的救生治疗是由医生进行的 未经训练的旁观者，经常处于极度压力的情况下。 纳洛酮逆转阿片类药物过量影响的益处已得到明确证明。 今天最紧迫的问题是纳洛酮的给药方法最有效 对于未经训练的旁观者。研究表明，自动注射器 (AIJ) 提供了低成本、安全性、 可靠性、人体工程学设计，最重要的是纳洛酮的快速故障安全注射。为此，皮鲁埃特 Medical 开发了一种新颖且专有的 AIJ 平台，该平台基于之前的 AIJ QUICPUSH，用于 肾上腺素注射液，可用于正确、安全地进行肌内注射纳洛酮注射液 容易地。我们的纳洛酮自动注射器 (NAIJ) REZQGO 是一种薄型盘形注射装置，具有 以患者为中心，注重可负担性、便携性和可用性。其直观的设计使能力有限的个人能够 或者没有接受过轻松地为自己或他人注射的培训。 AIJ 的物理设计允许 简单、无压力的自我给药，最大限度地减少意外给药、割伤、针头的风险 棍棒或其他伤害。该装置可通过各种衣物安全有效地注射救生药物 材料。最后，REZQGO 设计具有多功能性，可以进行调整以适应各种情况 体积和其他参数变化，例如未来药物的剂量和针注射深度 配对。 在第一阶段，我们将严格验证 REZQGO 自动装置的非 GMP 原型的设计和可用性。 注射器。二期目标是生产三个GMP注册批次，完成全套 设计验证测试，并通过 505(b)(2) 途径向 FDA 提交 NDA 以获得监管批准，使用 QUICPUSH 和其他商业可用的 AIJ 项目作为谓词设备。总体而言，该项目将有助于 向市场推出一种新型低成本设备，任何人都可以使用它来安全地输送救生盐酸纳洛酮 阿片类药物过量时注射，USP 肌肉注射。