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

项目摘要 从2019年到2020年，美国服药过量死亡人数同比增长30%；每天有187人死于 美国的阿片类药物过量。纳洛酮显著降低了阿片类药物的死亡率，增加了作为 紧急救援和住院前的第一线救生措施。盐酸纳洛酮注射剂，USP (纳洛酮)是一种阿片类拮抗剂，能迅速逆转过量服药并迅速恢复正常呼吸。它可以 给任何有服药过量迹象的人服用。纳洛酮不存在滥用/上瘾的可能性。 这种药物价格低廉，在所有50个州都可以买到，通常没有处方。救护车和医院 手头有纳洛酮，并有经过培训的医务人员管理它；然而，寻求帮助或前往急诊室是 往往为时已晚。至少40%的时间，阿片类药物过量的救命治疗是由 未经训练的旁观者，通常在极度紧张的情况下。 纳洛酮在逆转阿片类药物过量效应方面的益处已经得到确凿的证明。 那么，现在最紧迫的问题就是纳洛酮的给药方法是最有效的 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、 可靠性，符合人体工程学的设计，最重要的是快速故障安全注射纳洛酮。在这一端，旋转 Medical已经开发了一个新颖的专有AIJ平台，基于之前的AIJ QUICPUSH 肾上腺素注射，可以改装成安全地肌肉注射纳洛酮正确和 很容易。我们的纳洛酮自动注射器(NAIJ)REZQGO是一种低调的盘状注射器，具有 以患者为中心，注重可负担性、便携性和易用性。其直观的设计使有限的个人 或者没有接受过容易地给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，最大限度地减少不慎给药、割伤、打针的风险 棍棒，或其他伤害。该装置可以安全有效地通过各种衣物注射救命药物 材料。最后，REZQGO的设计是多才多艺的，可以调整以适应各种不同的 体积和其他参数的变化，如给药剂量和针头注射深度 配对。 在第一阶段，我们将严格验证我们的REZQGO汽车的非GMP原型(S)的设计和可用性- 注射器。在第二阶段，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提交保密协议以供监管批准，使用 QUICPUSH和其他商业上可用的AIJ项目作为谓词装置。总体而言，这个项目将有所帮助 将一种新的低成本设备推向市场，任何人都可以使用该设备安全地提供挽救生命的盐酸纳洛酮 注射，在阿片类药物过量期间肌肉注射。

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.