High-dose opioid reversal spray no better than lower dose in field, US
study finds
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[February 09, 2024]
(Reuters) - A high-dose version of the opioid reversal spray
naloxone, made by Hikma Pharmaceuticals, did not result in an increased
survival rate compared with lower-dose versions of the drug when
administered in emergency situations by New York law enforcement,
according to a U.S. study.
The analysis also suggests that those given the higher 8 milligram
strength spray were more than twice as likely to experience opioid
withdrawal symptoms compared to other sprays such as Narcan that use a 4
mg dose.
Naloxone rapidly reverses or blocks the effects of opioids, restoring
normal respiration, especially when given within minutes of the first
signs of an overdose.
The Hikma version, 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 that a high-dose version was
needed to respond to overdoses by more potent opioids such as fentanyl.
The U.S. opioid epidemic has caused more than a half million overdose
deaths over more than two decades, with fentanyl and synthetic versions
a major culprit in recent years, according to government data.
According to the 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 employees and published on Thursday by
the U.S. Centers for Disease Control and Prevention, analyzed 436
detailed reports from New York State Police troopers from March 26, 2022
through Aug. 16, 2023. The reports included body-worn camera footage.
This was the first real-world data comparing the two doses and aligns
with an earlier systemic review of reports from emergency departments,
the study authors said.
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Paramedics display a dose of the opioid overdose reversal drug
Narcan, or Naloxone Hydrochloride, in an ambulance in Peabody,
Massachusetts, U.S., August 8, 2017. REUTERS/Brian Snyder/File Photo
Among those who received 8 mg
naloxone, 37.6% showed signs of opioid withdrawal including
vomiting, compared with 19.4% for those who got the 4 mg dose, the
data showed.
Opioid withdrawal symptoms associated with the use of naloxone
include vomiting, disorientation, lethargy, shivering, diarrhea and
increased heart rate.
"Those on the frontlines of this public health epidemic need all
FDA-approved treatment options available to them, which is why Hikma
provides 8 mg nasal Kloxxado and generic injectable naloxone options
to help meet the urgent needs of patients and communities," the
company said in a statement.
The study authors said their findings were limited by the fact that
police personnel were not medical providers and that there may have
been inconsistencies in the classification of post-naloxone
administration symptoms.
Emergent Biosolutions' Narcan, the first nasal spray emergency
treatment for opioid overdose, was approved by the FDA in 2015 as a
prescription drug at a 4 mg dose.
Apart from Emergent, Israel-based Teva Pharmaceutical Industries,
Padagis Israel Pharmaceuticals and Amphastar Pharmaceuticals also
manufacture 4 mg versions of naloxone nasal spray.
(Reporting by Mariam Sunny in Bengaluru; editing by Caroline Humer
and Bill Berkrot)
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