(Reuters) – A high-dose version of the opioid withdrawal spray naloxone made by Hikma Pharmaceuticals (over-the-counter) did not result in improved survival compared with lower-dose versions of the drug when administered in emergency situations in New York. law enforcement, according to a US study.
The analysis also shows that those who received the higher-dose 8-milligram spray were more than twice as likely to experience opioid withdrawal symptoms compared to other sprays, such as Narcan, which use a 4-milligram dose.
Naloxone quickly reverses or blocks the effects of opioids, restoring normal breathing, especially if administered within minutes of the first signs of an overdose.
A version of Hikma, sold under the brand name Kloxxado, was approved in 2021 after U.S. Food and Drug Administration advisers and National Institutes of Health reports suggested a high-dose version was needed to respond to overdoses from stronger opioids such as fentanyl.
The opioid epidemic in the United States has caused more than half a million overdose deaths over more than two decades, with fentanyl and its synthetic versions the main culprit in recent years, according to government data.
In a field study, 99.0% of those who received 8 mg of intranasal naloxone survived, as did 99.2% of those who received 4 mg.
The study, conducted by New York City officials and released Thursday by the U.S. Centers for Disease Control and Prevention, analyzed 436 detailed reports from New York State Police officers from March 26, 2022, to Aug. 16, 2023. camera footage.
This was the first real-world data comparing the two doses, the study authors said, and is consistent with an earlier systematic review of emergency department reports.
The data showed that among those who received 8 mg of naloxone, 37.6% experienced signs of opioid withdrawal, including vomiting, compared with 19.4% among those who received the 4 mg dose.
Opioid withdrawal symptoms associated with naloxone use include vomiting, confusion, lethargy, tremors, diarrhea, and rapid heartbeat.
“Those on the front lines of this public health epidemic need all the FDA-approved treatment options available to them, which is why Hikma offers 8 mg nasal cloxado and generic injectable naloxone options to help meet the critical needs of patients and communities,” the company said . in the statement.
The study authors said their results were limited by the fact that the police officers were not medical professionals and that there may have been inconsistencies in the classification of symptoms following naloxone administration.
Emergent Biosolutions (NYSE:)’ Narcan, the first nasal spray for emergency treatment of opioid overdose, was approved by the FDA in 2015 as a 4 mg prescription drug.
In addition to Emergent, Israeli companies Teva Pharmaceutical Industries (NYSE:), Padagis Israel Pharmaceuticals and Amphastar Pharmaceuticals (NASDAQ:) also produce 4 mg versions of naloxone nasal spray.