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，美国过量死亡人数同比增加30%;每天有187人死于 阿片类药物过量在美国纳洛酮作为阿片类药物，随着使用量的增加， 急救和住院治疗前的一线救生措施。盐酸纳洛酮注射液，USP （纳洛酮）是一种阿片类拮抗剂，可迅速逆转过量并迅速恢复正常呼吸。它可以 给任何有过量迹象的人服用。纳洛酮不存在滥用/成瘾的可能性。 这种药物成本低，在所有50个州都可以买到，通常没有处方。救护车和医院 手头上有纳洛酮，医务人员接受过管理培训;然而， 往往为时已晚至少有40%的时间，阿片类药物过量的挽救生命的治疗是由一个 未经训练的旁观者，通常在极端压力的情况下。 纳洛酮逆转阿片类药物过量效应的益处已得到最终证明。 现在最紧迫的问题是纳洛酮的哪种给药方法最有效 没有受过训练的旁观者。研究表明，自动注射器（AIJ）提供了低成本，安全， 可靠性，人体工程学设计，最重要的是纳洛酮的快速故障安全注射。在这方面，Pirouette 医疗已经开发了一个新颖的专有AIJ平台，基于以前的AIJ QUICPUSH， 肾上腺素注射剂，可适用于安全地正确输送纳洛酮肌内注射剂， 轻易我们的纳洛酮自动注射器（NAIJ）REZQGO是一种低轮廓、盘形注射装置， 以患者为中心，注重可负担性、便携性和可用性。其直观的设计允许个人有限的 或者没有训练来容易地对自己或他人进行注射。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、撕裂、针头 或其他伤害。该装置可以通过各种衣物安全有效地注射救命药物 材料.最后，REZQGO的设计是通用的，可以进行调整，以适应各种各样的 体积和其他参数变化，例如输送的剂量和未来药物的针头注射深度 配对 在第一阶段，我们将严格验证我们的REZQGO自动化的非GMP原型的设计和可用性。 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NDA以获得监管批准，使用 QUICPUSH和其他市售AIJ项目作为同品种器械。总的来说，这个项目将有助于 将一种新颖的低成本设备推向市场，任何人都可以使用它来安全地提供救命的盐酸纳洛酮 注射，USP在阿片类药物过量期间肌内注射。

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.