Pocket Naloxone Corp. announced positive results from a human factors validation study of its NaxSwab™ OTC naloxone nasal swab, indicating that laypersons, including children and adults, can effectively administer the product in simulated opioid overdose scenarios. The study, which used the intended-to-market packaging and labeling, demonstrated that participants of varied ages and reading comprehension levels, as well as healthcare professionals (HCPs), could successfully use NaxSwab™ OTC to potentially revive someone from an opioid overdose.
The study enrolled sixty participants divided into four cohorts: Naive Passersby, Adult Patients and Lay Caregivers, Adolescents (ages 10-17 years), and a mix of HCPs including paramedics, pharmacists, and nurses. Conducted by Eurofins Human Factors MD, the study simulated a home setting where participants were asked to administer the product to a manikin lying prone on the floor, mimicking an emergency rescue situation. Participants were not allowed to review the packaging or instructions beforehand, and approximately 30% of subjects in each non-HCP cohort had low literacy rates.
Study Findings
The results indicated that almost all (41 of 45) lay participants and all 15 HCP participants were able to administer an initial dose, call for emergency help, and administer a second dose if symptoms persisted or returned. Few issues that could have impacted dosing were identified, and these were primarily observed in lay participants with 4th-8th grade reading levels. According to Pocket Naloxone Corp, label enhancements led to a 100% success rate in the 'Call 911' step, meeting FDA expectations.
Faster Naloxone Absorption
NaxSwab™ OTC is designed for simple, ready-to-use naloxone delivery, with the potential for faster early absorption. Naloxone, an opioid antagonist, works by blocking the effects of opioids at opioid receptors. Faster absorption could be advantageous in counteracting potent synthetic opioids like fentanyl. Previous pharmacokinetic (PK) studies showed that NaxSwab™ OTC was associated with a 10-fold higher naloxone exposure (AUC) at 2.5 minutes post-dose and a more than 3-fold higher naloxone exposure at 5 minutes post-dose compared to a 0.4 mg intramuscular naloxone reference product. Compared to a 4 mg naloxone spray, NaxSwab™ OTC showed a 74% higher naloxone exposure at 2.5 minutes and a 19% higher exposure at 5 minutes.
Company Vision
"It's critical to make naloxone more accessible to the community. Our company's mission has always been to develop a low-priced naloxone product to be truly affordable and accessible that at the same time demonstrates faster early absorption into the bloodstream to meet this moment with fentanyl and is easy to use," said Ashanthi Mathai, CEO and Co-founder of Pocket Naloxone Corp. "To that point, we are pleased that our human factors validation study results show that our simple, ready-to-use naloxone nasal swab can be correctly administered by children and adults."
