US-based startup Pocket Naloxone said that a human factors study of its NaxSwab OTC naloxone nasal swab demonstrated that the swab could be used effectively in a simulated emergency by a wide range of people, including adolescents. The company said that 41 of 45 lay people and 15 of 15 healthcare professionals who participated in the study were able to successfully execute the steps necessary to revive a patient suffering from an opioid overdose.
The study, which was conducted by Eurofins Human Factors MD, involved participants as young as 10 years old using the swab “in a home setting while exposed to stressors, to render aid to a manikin lying prone on the floor.” Participants, including people with low literacy in the lay group, were asked to deliver a dose of naloxone, call for help, and deliver a second dose to treat persistent symptoms without being allowed to read the instructions prior to the simulated emergency. According to Pocket Naloxone, “Very few issues that could have impacted dosing were identified, all of which were observed in lay participants with 4th-8th grade reading levels.”
The company previously reported results from a PK study of NaxSwab OTC in which the swab produced naloxone exposure that was 74% higher at 2 1/2 minutes post dose and almost 20% higher at 5 minutes post dose compared to a 4 mg naloxone spray.
Pocket Naloxone CEO Ashanthi Mathai commented, “We noted the advisory committee’s unanimous vote to approve OTC naloxone nasal spray in February of this year. 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. 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.”
According to the announcement, Pocket Naloxone is developing additional products based on the nasal swab delivery system.
Read the Pocket Naloxone press release.
