News

Richmond, Va. (September 8, 2016) – Kaléo, a privately-held pharmaceutical company, today announced findings from two studies comparing intramuscular injection and intranasal administration of naloxone, a drug used for the emergency treatment of opioid overdose. The studies, which represent kaléo’s commitment to advancing the understanding of naloxone use in opioid emergencies, will be presented at PAINWeek 2016 on Thursday, September 8.

In one study (poster #35), non-medically trained participants were asked to administer naloxone using EVZIO® (naloxone HCl injection) Auto-injector and an improvised naloxone intranasal kit during a simulated opioid emergency, with and without prior training on how to use the devices. The study found that 100% and 97.6% of participants were able to administer EVZIO with and without training, respectively, compared to 43.9% and 0% with the improvised naloxone intranasal delivery system, respectively (p<0.0001).

“The results of this study illustrate the importance of incorporating human factors engineering into the design of naloxone products intended for use in the community setting where family, friends and caregivers of those taking an opioid may be in the best position to quickly intervene during a life-threatening opioid emergency.” said Evan Edwards, Vice President, Product Decelopment & Industrialization at kaléo. “This study demonstrates that EVZIO, which was the first naloxone product specifically designed, FDA approved and labeled for use in the community setting based on human factors engineering studies, can play an important role in successful administration of naloxone by a non-medically trained person during a life-threatening opioid emergency.”

The second study (poster #65) compared the pharmacokinetics of 2.0 mg naloxone administered to volunteers with chronic rhinitis by intramuscular injection, intranasal administration, and intranasal administration after treatment with Afrin®, a common over-the-counter nasal decongestant/vasoconstrictor. The pharmacokinetics showed that intranasal naloxone absorption was slower and resulted in overall lower exposure in patients who received Afrin® prior to their naloxone dose. Additionally, the study showed that naloxone administered by intramuscular injection demonstrated greater bioavailability compared to naloxone administered intranasally using an improvised intranasal naloxone kit.

“This study was specifically designed to examine the impact of a common over-the-counter nasal medication on the absorption of naloxone,” said Eric Edwards, Vice President, Product Strategy at kaléo. “We’ve found that an over-the-counter nasal decongestant used for a common medical condition that affects the nasal passage, may impact the absorption of naloxone into the body when naloxone is administered intranasally using an improvised intranasal naloxone kit. These are important factors for a healthcare professional to consider when prescribing naloxone for take-home use as part of a patient’s opioid emergency plan.”

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