Evidence map›Paper›PMID 40796531›Full record

Trial reportJournal of clinical pharmacology2025

Reversal of Fentanyl-Induced Respiratory Depression in Healthy Subjects by Intramuscular Nalmefene Administered by Auto-Injector Versus Intranasal Naloxone.

Alessandra Cipriano, Ellie He, Manjunath Shet, Glen Apseloff, Stephen C Harris

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Alessandra CiprianoImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, Connecticut, USA.
Ellie HeImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, Connecticut, USA.
Manjunath ShetImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, Connecticut, USA.
Glen ApseloffOhio Clinical Trials, LLC, Columbus, Ohio, USA.
Stephen C HarrisImbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., Stamford, Connecticut, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As illegally made fentanyl and congeners continue to drive overdose deaths in the US, experts have called for stronger and longer-lasting antagonists. A randomized, 4-period, 2-treatment crossover replicate-design study in healthy moderately-experienced opioid users (n = 24) evaluated the reversal of opioid-induced respiratory depression (OIRD) by intramuscular (IM) nalmefene 1.5 mg administered by auto-injector delivering a formulation developed for faster onset, compared to intranasal (IN) naloxone 4 mg. Fentanyl infusions were administered to induce a 50% reduction in minute ventilation (MV). Reversal of OIRD, pharmacokinetics, and safety were investigated under steady-state fentanyl agonism. For the primary endpoint, nalmefene demonstrated superiority at 5 min with an MV increase of 4.59 L/min, more than twice the 1.99 L/min increase for naloxone (P < .0001). Nalmefene superiority was also demonstrated at 10, 15, 20, and 30 min, while non-inferiority was demonstrated at 2.5 and 90 min. The time-course of mean antagonist concentrations correlated with increases in mean MV, peaking at approximately 5-10 min following nalmefene compared to 20-30 min following naloxone. Decreases in transcutaneous CO

Indexed as

Analgesics, OpioidFentanylNaloxoneNaltrexoneNarcotic AntagonistsRespiratory InsufficiencyAdministration, IntranasalAdultCross-Over StudiesFemaleHealthy VolunteersHumansInjections, IntramuscularMaleMiddle AgedYoung AdultAnalgesics, OpioidFentanylnalmefeneNaloxoneNaltrexoneNarcotic AntagonistsNalmefeneopioid antagonistopioid‐induced respiratory depressionopioid overdose reversaloverdose

Identifiers

PMID40796531
PMCPMC12649286

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.