People receiving a double dose of naloxone are not any extra more likely to survive an opioid overdose than folks receiving an ordinary, 4-milligram nasal spray, in line with a brand new examine.
The brand new paper, revealed Thursday within the Facilities for Illness Management and Prevention’s Morbidity and Mortality Weekly Report, confirmed no important distinction in survival charges between individuals who have been revived utilizing 4- and 8-milligram sprays of naloxone, generally recognized by the model identify Narcan. Individuals receiving the smaller dose additionally didn’t require a better whole variety of sprays, regardless of having obtained simply half the preliminary quantity. The researchers discovered just one main distinction between these receiving completely different dose sizes: Those that obtained a double dose have been over 2.5 occasions extra more likely to expertise extreme withdrawal signs, like vomiting.
The examine comes as pharmaceutical corporations proceed to market costly high-dose formulations of naloxone, arguing that amid report drug loss of life ranges ensuing from potent artificial opioids like fentanyl, it’s important to ship as a lot of the overdose-reversal treatment as doable. Public well being consultants and harm-reduction teams have pushed again, nonetheless, charging that the businesses have used Individuals’ worry of fentanyl as an excuse to promote needlessly costly naloxone merchandise to cash-strapped public well being businesses.
“For-profit pharma has been attempting to wring income from this public well being emergency for years,” stated Michael Hufford, the CEO of a nonprofit naloxone producer, Hurt Discount Therapeutics. “It jogs my memory of the quote from Upton Sinclair: ‘It’s tough to get a person to know one thing, when his wage depends upon his not understanding it.’ Most not too long ago, gross sales reps have been pushing consumers to buy high-dose naloxone merchandise, regardless of understanding that extra naloxone is just not solely typically not required for profitable reversals, however dramatically will increase the danger of significant withdrawal.”
Naloxone is broadly utilized by first responders, harm-reduction teams, and individuals who use medicine to reverse opioid overdoses. It really works by forcing opioid molecules off of the mind receptor they’d beforehand grabbed onto — shortly reversing the opioids’ results, however within the course of, typically inducing painful withdrawal signs within the particular person being revived.
As fentanyl has come to dominate the U.S. illicit drug market, some first responders have voiced fears that lower-dose naloxone merchandise, like Narcan or cheaper injectable variations, won’t be enough to reverse overdoses. And as xylazine, a veterinary tranquilizer, has entered the drug provide, overdose reversals have turn out to be much more sophisticated: In lots of instances, folks experiencing an overdose don’t regain consciousness even after they’re given a number of naloxone doses.
However extra naloxone is just not all the time higher, in line with main harm-reduction teams. As an alternative, a rising physique of proof, together with a separate systematic review revealed in 2023, means that an excessive amount of naloxone can have important penalties.
Experiencing painful withdrawal is just not solely uncomfortable, however typically harmful: In lots of instances, folks experiencing extreme signs rush to make use of opioids once more in an effort to alleviate their ache, probably resulting in a second overdose nearly instantly following the primary.
Many first responders and harm-reduction teams have tailored their overdose reversal protocols to incorporate rescue respiration methods and supplementary oxygen.
Nonetheless, quite a few drug corporations have continued to develop and market higher-dose naloxone merchandise, arguing they’re a essential element of the U.S. overdose-prevention effort.
However they’re far costlier than lower-dose merchandise: Generic, injectable naloxone usually sells for just some {dollars} per dose, and previously decade Pfizer, its largest producer, has given away tens of millions of doses without cost.
Two nasal sprays permitted for over-the-counter gross sales — Narcan, a 4-milligram nasal spray, and RiVive, a 3-milligram competitor offered by Hurt Discount Therapeutics — usually retail for roughly $50 and $36, respectively.
Whereas costs range by metropolis and by particular pharmacy, higher-dose naloxone merchandise are usually far costlier than a generic injectable model generally utilized by first responders or harm-reduction teams. A two-pack of Kloxxado, an 8-milligram nasal spray that’s an identical to Narcan in all however dose, retails for roughly $140 for a two-pack. Zimhi, a 5-milligram prefilled syringe, additionally prices roughly $140 for a two-pack.
Individually, the drug producer Káleo confronted important blowback after advertising and marketing a 5-milligram mechanized auto-injector, full with a speaker that performed recorded directions to customers as they reversed an overdose. Its retail value: $4,100.
That gadget has since discovered a second life, nonetheless, with the Pentagon. In 2022, the corporate obtained approval from the Meals and Drug Administration in a 10-milligram model designed to be used by army personnel or first responders who encounter “fentanyl analogues as a chemical weapon” or “coming into an space contaminated with high-potency opioids comparable to fentanyl analogues.” U.S. army personnel usually are not recognized to have ever encountered fentanyl on a battlefield, and its army purposes are unclear, save for one alleged use by Russian forces throughout a 2002 hostage disaster in Moscow.
Following its approval, the Division of Protection positioned an order for as many as 788,000 injector kits.
The examine revealed Thursday was carried out by the New York State Division of Well being, which had beforehand distributed each the 4- and 8-milligram dosages to state police in an effort to assemble information about their relative efficacy. New York State Police, in flip, filed detailed stories to the general public well being division, which used the info in formulating its evaluation.
“No advantages to administration of 8-mg intranasal naloxone in contrast with [the] 4-mg product have been discovered,” the examine’s authors wrote, including that the examine was probably restricted by its geographic scope and pattern measurement.
In a press release, Steven Weiss, a spokesperson for Hikma, the producer of Kloxxado, cited previous research that voiced considerations that decrease naloxone doses are inadequate within the fentanyl period.
“These on the frontlines of this public well being epidemic want all FDA-approved remedy choices obtainable to them, which is why Hikma offers 8 mg nasal Kloxxado and generic injectable naloxone choices to assist meet the pressing wants of sufferers and communities,” he stated.
DMK Prescribed drugs, which manufactures Zimhi, didn’t reply to STAT’s request for remark.
STAT’s protection of continual well being points is supported by a grant from Bloomberg Philanthropies. Our monetary supporters usually are not concerned in any choices about our journalism.
