01 Dec, 2022, 11:10 ET
Pharmacokinetic study data in healthy volunteers shows NaxSwab™ OTC has 74% and 1096% higher exposures at 2.5 minutes compared to naloxone HCI 4mg nasal spray and 0.4mg IM naloxone injection
BETHESDA, Md., Dec. 1, 2022 /PRNewswire/ -- Pocket Naloxone Corp., a startup pharmaceutical company with the vision of enhancing naloxone delivery, today announced positive results from its human pharmacokinetic (PK) study of its novel naloxone nasal swab NaxSwab™. The study was a randomized, crossover, comparative bioavailability study that enrolled sixty healthy volunteers to evaluate naloxone absorption against the primary reference drug 0.4mg intramuscular (IM) naloxone injection and against naloxone HCI 4mg nasal spray as a secondary comparator. Results indicate more rapid absorption against these reference naloxone products and good safety and tolerability.
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. For the critical early exposure period, in the PK study, NaxSwab™ 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™ 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.
"Our unique naloxone nasal swab dosage form, which is under final stages of development, is purpose-built as a simple ready-to-use product designed for faster, higher early absorption," commented Ashanthi Mathai, CEO and Co-founder of Pocket Naloxone Corp. "We are committed to making it affordable and conveniently purchasable in retail stores and online as an OTC product. Potentially to help save a family from losing a loved one from an opioid overdose, which is now happening every six to seven minutes in the US."
"The opioid epidemic and opioid poisonings continue to rage unchecked by every intervention to date," noted Dr. Andrea Barthwell, Pocket Naloxone's Board Liaison for Science & Policy and a former President of the American Society for Addiction Medicine and Deputy Director for Demand Reduction in the George W. Bush White House Office of National Drug Control Policy. "Overdose deaths continue at an alarming rate making the need for naloxone products purchased with opioid prescriptions and readily available in the community where non-medical use occurs an urgent priority."
The Food and Drug Administration (FDA) recognizes the importance of having OTC naloxone products available and on November 15, 2022, issued a Federal Register (FR) notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, along with a statement noting that the steps outlined in the FR Notice, "may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status." The notice also stated that 9.3 million units of naloxone were sold in 2021 from analyses performed using the IQVIA National Sales Perspectives data. This excluded donations and public health channels not included in the IQVIA dataset. The CDC estimates that 9 million high dose opioid prescriptions are not paired with naloxone as would be recommended. The company sees an opportunity to serve the large and growing unmet need for an affordable OTC naloxone product in the community setting.
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.
Media Contact: Kathleen Van Gorden, [email protected]
SOURCE Pocket Naloxone Corp.
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