CounterAct has announced results from a human factors / usability study of its nasal spray cap device that included a simulated rescue in an opioid overdose scenario. The CounterAct device, which is designed to snap onto a prescription pill bottle, contains a single dose of naloxone. According to the company, the average time required for participants in the study to administer naloxone to a mannequin using the Counteract System was less than 19 seconds.
The study included 15 participants aged 10-71 who were provided with instructions but no training, the company said. Participants were given one opportunity to perform a simulated rescue using the device, then had “a discussion related to their experience” before performing the simulated rescue again. Counteract said that all 15 participants understood the instructions and were able to remove the cap, unfold the nozzle, insert the nozzle into a nostril and press the activation button at least once; although a third of the participants expressed concern about how far to insert the nozzle.
CounterAct co-founder Todd Pizitz commented, “We developed this rescue medication device because we know an overdose, seizure, or some sort of anaphylactic reaction can occur, and the counter agent is not always nearby. Pairing the prescription medication with the rescue medication in one device has been our mission to help save lives from opioid overdoses and other related emergency medical situations. We are pleased with the results of the HFS.”
The company is pursuing the 505(b)(2) pathway for the CounterAct System. The nasal spray cap is covered by patents in the US and in Canada.
Read the CounterAct press release.
