Trial Shows Fast-Absorbing Opioid Overdose Nasal Swab

(Ewa Urban, Pixabay. https://pixabay.com/photos/medical-pharmacy-illness-get-sick-342446/)

2 Dec. 2022. Results of a clinical trial show a nasal swab dispensing an opioid antidote transfers more of the antidote into the blood stream than syringe injections or nasal sprays. Findings from the trial were released by Pocket Naloxone Corp. in Bethesda, Maryland, developer of the nasal swab, and are not peer-reviewed.

Opioids were originally developed and prescribed for pain relief, but have been overtaken by dependence and abuse leading to many overdoses. Opioid compounds attach to receptors on nerve cells in the brain relieving the pain, but also inducing euphoria. Continual use of opioids, even when prescribed, can lead to dependence and abuse, driving sales of street drugs, such as heroin and fentanyl, with overdose deaths from those drugs reaching nearly 92,000 in 2020, according to data from the Centers for Disease Control and Prevention.

Pocket Naloxone is developing over-the-counter treatments to help counteract the growing number of opioid overdoses and deaths. Naloxone is an opioid antagonist which, like opioids, attaches chemically to nerve cell receptors, but reverses and blocks effects of opioids, enabling breathing to be restored in people taking an overdose. Last month, the Food and Drug Administration issued a preliminary assessment that naloxone could be sold without a prescription in prefilled syringes or as a nasal spray. But the agency said it still requires more data to support approval of over-the-counter naloxone drugs, particularly to distinguish them from prescription naloxone treatments.

Measured naloxone concentrations in blood samples

Pocket Naloxone is a start-up enterprise, whose first product is a nasal swab, called NaxSwab, to dispense naloxone in people experiencing an opioid overdose. The company says it seeks to make NaxSwab readily available and at low cost. Earlier this year, Pocket Naloxone began an early-stage clinical trial planning to enroll 76 healthy adults to test the swabs’ chemical activity in the body, against other ways to deliver naloxone under consideration for over-the-counter or OTC sale: syringe injections and nasal sprays. Participants were randomly assigned to first test NaxSwabs at low, medium, and high dosage levels in one nostril or receive naloxone injections or nasal sprays, then later reverse the delivery methods to receive naloxone with the alternative technique.

The study team measured naloxone concentrations in blood samples of participants at 2.5 and five minutes after taking the drug. The company says results from 60 participants show after 2.5 minutes, those using a NaxSwab have 10 times more naloxone in their blood than injection recipients and 74 percent more naloxone than nasal spray users. After five minutes, NaxSwab users have three times more naloxone in their blood than injection recipients and 19 percent more naloxone than nasal spray users. The study team is also tracking reports of adverse effects, such as skin irritation, from the nasal swabs, but other than general “good safety and tolerability” comments, no details on safety were reported.

“Our unique naloxone nasal swab dosage form, which is under final stages of development,” says Pocket Naloxone co-founder and CEO Ashanthi Mathai in a company statement released through Cision, “is purpose-built as a simple ready-to-use product designed for faster, higher early absorption. We are committed to making it affordable and conveniently purchasable in retail stores and online as an OTC product.”

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