13 Apr, 2023, 10:10 ET
Human Factors Validation Study demonstrated that adolescents and adults could follow the instructions to correctly administer NaxSwab™ OTC in a simulated emergency environment
BETHESDA, Md., April 13, 2023 /PRNewswire/ -- Pocket Naloxone Corp., a startup pharmaceutical company with the vision of enhancing naloxone delivery, announced results from a human factors validation study, using the intend-to-market packaging and labeling, demonstrated that laypersons of varied ages and reading comprehension levels and HCPs (healthcare professionals) were successfully able to administer its novel naloxone nasal swab NaxSwab™ in a simulated emergency rescue environment to potentially revive someone from an opioid overdose. The study enrolled sixty participants in four 15-member cohorts, pre-defined by the FDA, encompassing Naïve Passersby, Adult Patients and Lay Caregivers, Adolescents with ages 10-17 years and a mix of HCPs comprising paramedics, pharmacists and nurses.
The study was conducted by Eurofins Human Factors MD. Participants were asked to use the product in a home setting while exposed to stressors, to render aid to a manikin lying prone on the floor. They were not allowed to read the packaging or instructions ahead of time and at least about 30 percent of subjects in each non-HCP cohort had low literacy rates. Results showed 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 when symptoms persisted or returned. 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 FDA had requested that efforts be made to obtain an improved success rate relative to FDA's CONFER LCS study for the 'Call 911' step and with appropriate label enhancements, a 100% success rate was achieved in the company's current study.
Naloxone is an opioid antagonist that acts by blocking the effects of opioids at the opioid receptors. Clinical practitioners believe that faster naloxone absorption into the bloodstream could provide an advantage to help revive someone in the presence of highly potent synthetic opioids like fentanyl. Previously, the company reported that for the critical early exposure period, in the PK study, NaxSwab™ OTC was associated with a 10-fold higher naloxone exposure (i.e., AUC or area under the curve) at 2.5 minutes post dose and more than a 3-fold higher naloxone exposure at 5 minutes post dose compared to the 0.4 mg IM naloxone reference product. NaxSwab™ OTC was associated with a 74% higher naloxone exposure at 2.5 minutes post-dose and 19% higher naloxone exposure at 5 minutes post-dose compared to 4 mg naloxone spray.
"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," commented 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."
About Pocket Naloxone Corp.
Pocket Naloxone Corp.'s vision is to help in facilitating a world free of opioid overdose deaths and its mission is to meet the FDA's unprecedented call for an OTC naloxone product. The company's goal is to make its NaxSwab™ naloxone nasal swab available at a low, affordable cost once approved to be accessible regardless of insurance coverage and other factors. The company has other pipeline assets in development utilizing the same nasal swab applicator delivery platform. www.pocketnaloxone.com.
About Eurofins Human Factors MD
Eurofins Human Factors MD, LLC is one of the preeminent leaders in the human factors industry who have played a critical role in many successful regulatory submissions, several of which are emergency-use products. The company's mission is to help pharmaceutical and medical device companies develop products that are both usable and accessible by developing and executing upon rigorous human factors tests to ensure this is the case.
SOURCE Pocket Naloxone Corp.
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