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

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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.