Reversing opioid overdose: Concentrated naloxone nasal spray as good as injection

November 16, 2017, Society for the Study of Addiction

A new study published by the scientific journal Addiction has found that a concentrated 2mg intranasal naloxone spray delivers naloxone as effectively, over the critical first 15 minutes, as the standard 0.4mg intramuscular (IM) naloxone injection. The 2mg spray also maintains blood levels of naloxone more than twice as high as the 0.4mg IM levels for two hours after administration. It should therefore be highly effective in reversing opioid overdose.

These results support the recent announcement on 14 September 2017 that the European Medicines Agency (EMA) has issued a positive opinion for a 1.8 mg naloxone nasal formulation (equivalent to 2mg naloxone hydrochloride), under the brand name Nyxoid.

Take-home naloxone (naloxone kits provided to drug users and other non-medical persons for use in emergency situations) helps to prevent death from heroin/. Naloxone is usually given by injection, but more user-friendly non-injectable alternatives are being developed, including . To be effective, the intranasal spray must be highly concentrated to achieve good absorption, the dose must be adequate but not excessive, and early absorption should be comparable to IM injection.

This study tested nasal naloxone at 1mg, 2mg, and 4mg doses on 38 healthy volunteers, compared with 0.4mg IM and 0.4mg intravenous doses. Each volunteer received all five study treatments, with one naloxone dose per session and each session separated by a washout period. Blood plasma concentrations of naloxone were measured nineteen times for each volunteer during each treatment session, with intense sampling in the first 15 minutes after dosing.

All three doses of naloxone nasal spray were well absorbed, with the 2mg spray most closely replicating the performance of the 0.4mg IM naloxone injection over the critical first 15 minutes. The volunteers experienced no severe adverse effects; the main mild adverse effect was headache, in six volunteers.

Professor Sir John Strang of King's College London, who co-authored the report, is cautiously optimistic: "Our findings demonstrate good early absorption and overall bioavailability of naloxone in healthy subjects, but concentrated naloxone nasal spray has yet to be formally tested in the target population of opioid users. Nasal naloxone might be absorbed differently by due to damaged , rhinitis, or from mucus or vomit during overdose. Nevertheless we are very pleased that concentrated nasal naloxone formulations are now receiving regulatory approval and believe that they will help widen the provision of take-home and thereby save lives."

Explore further: Improvised naloxone nasal sprays lack evidence of absorption and effect

More information: Rebecca McDonald et al, Pharmacokinetics of concentrated naloxone nasal spray for opioid overdose reversal: Phase I healthy volunteer study, Addiction (2017). DOI: 10.1111/add.14033

Related Stories

Improvised naloxone nasal sprays lack evidence of absorption and effect

February 4, 2016
Naloxone hydrochloride is a medication that can reverse the effects of an opioid overdose. First responders (peers, family, police, etc.) may prefer nasal sprays to injectable naloxone, which has led to widespread use of ...

How to obtain and use the 'angel' therapeutic Naloxone

July 18, 2017
It's a terrifying scenario that's become all-too-real in the age of the opioid epidemic: a person lying lifeless, not breathing, because of an opioid overdose.

FDA approves nasal spray to reverse narcotic painkiller overdose

November 19, 2015
(HealthDay)—A nasal spray that treats narcotic painkiller and heroin drug overdoses has been approved by the U.S. Food and Drug Administration.

Extended-release naltrexone promising for opioid dependence

October 19, 2017
(HealthDay)—Extended-release naltrexone is noninferior to buprenorphine-naloxone for maintaining short-term abstinence from heroin and other illicit substances, according to a study published online Oct. 18 in JAMA Psychiatry.

Naloxone—an antidote to opioid overdose

August 31, 2016
Naloxone is an opioid antagonist, used as an "antidote" for opioid overdose which includes heroin, and opioid pain medicines such as morphine, fentanyl and codeine. It has been used since the 1970s by ambulance services and ...

Overdose prevention and naloxone rescue among family members of people who use opioids

April 29, 2017
Family members are often the ones who administer naloxone during an opioid overdose and should be considered as part of the larger response to help curb fatal overdoses. These findings, published online in Drug and Alcohol ...

Recommended for you

Marijuana use may not aid patients in opioid addiction treatment

December 4, 2017
Many patients who are being treated for opioid addiction in a medication-assisted treatment clinic use marijuana to help manage their pain and mood symptoms.

For opiate addiction, study finds drug-assisted treatment is more effective than detox

November 23, 2017
Say you're a publicly insured Californian with an addiction to heroin, fentanyl or prescription narcotics, and you want to quit.

Study finds medical cannabis is effective at reducing opioid addiction

November 17, 2017
A new study conducted by researchers at The University of New Mexico, involving medical cannabis and prescription opioid use among chronic pain patients, found a distinct connection between having the legal ability to use ...

Insomnia linked to alcohol-use frequency among early adolescents, says new psychology study

November 8, 2017
Insomnia is linked to frequency of alcohol use among early adolescents, according to new Rutgers University–Camden research.

Large declines seen in teen substance abuse, delinquency

October 25, 2017
More than a decade of data indicates teens have become far less likely to abuse alcohol, nicotine and illicit drugs, and they also are less likely to engage in delinquent behaviors, such as fighting and stealing, according ...

Trying to get sober? NIH offers tool to help find good care

October 3, 2017
The phone calls come—from fellow scientists and desperate strangers—with a single question for the alcohol chief at the National Institutes of Health: Where can my loved one find good care to get sober?

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.