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

Project Summary / Abstract The opioid crisis has touched every state in America, with 109,000 Americans dying of opioid overdose in 2022. According to the National Center for Drug Abuse Statistics, drug overdose deaths are up 30% year-over-year and opioids are a factor in 7 out of 10 of those overdose deaths. Naloxone is an opioid antagonist, that has persistently served as a critical frontline countermeasure since its approval by the FDA in 1971. When administered properly and in a timely fashion, Naloxone reverses respiratory depression caused by an opioid overdose; it’s saved countless lives and is the most important countermeasure and effective means to combating opioid overdoses globally. 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 in 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 Naloxone Auto-Injectors (NAIs) offer the best combination of pharmacokinetics, safety, reliability, ergonomic design, and most of all rapid fail-safe injection of Naloxone. Towards this end, Pirouette Medical has developed a novel, affordable, and proprietary NAI, based on our auto-injector platform that can be adapted to safely deliver intramuscular Naloxone injections correctly and easily. Our NAI, REZQGO, is a low-profile, disk-shaped, injection device with a patient-centric focus on affordability, portability, and usability. Its intuitive design aims to allow individuals with no training to easily administer an injection to others. The NAI’s physical design allows for simple and stress-free administration, minimizing the risk of accidental injections, lacerations, needle sticks, or other injuries. Pirouette is requesting an administrative supplement to address FDA feedback from our Type B pre-submission meeting with the FDA. Pirouette has refined the project objectives, adding additional research studies. Pirouette will add three Essential Performance Requirements to our testing regimen, conduct an in-vitro comparator study, and evaluate drug efficacy under cold and freezing temperatures which has received little attention in the counter- opioid market. Pirouette will also conduct an additional label development study for Human Factors. This will inform user compliance regarding emergency services notification – a critical aspect that the FDA has been unable to achieve with their DFL template for OTC devices. Achieving these additional milestones in Phase I will further de-risk the project for Phase II. The additional funds will help bring to market a novel, low-cost, OTC device that anyone could use to safely and rapidly deliver lifesaving Naloxone intramuscularly to reverse an opioid overdose.