Evidence map›Paper›PMID 31278694›Full record

Trial reportAdvances in therapy2019

A Randomized, Crossover Study on the Effect of Food on the Pharmacokinetic Characteristics of Morphine ARER (MorphaBond™ ER), an Abuse-Deterrent Formulation of Extended-Release Morphine.

Eric R Kinzler, Carmela Pantaleon, Matthew Iverson, Stefan Aigner

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

4 authors.

Eric R KinzlerInspirion Delivery Sciences, LLC, Morristown, NJ, USA. eric.kinzler@inspirionrx.com.
Carmela PantaleonInspirion Delivery Sciences, LLC, Morristown, NJ, USA.
Matthew IversonInspirion Delivery Sciences, LLC, Morristown, NJ, USA.
Stefan AignerInspirion Delivery Sciences, LLC, Morristown, NJ, USA.

Funding

CSRD VA 1
6 · The paper itself

Abstract

introductionFood can alter the pharmacokinetics of certain abuse-deterrent formulations. Morphine ARER is an oral abuse-deterrent formulation of ER morphine sulfate tablets formulated with physical and chemical properties that contribute to the abuse-deterrent aspects of the drug. This study compared the relative bioavailability of Morphine ARER in the presence and absence of food.

methodsThis was a randomized, single-dose, two-treatment, crossover study in which healthy adults received Morphine ARER 100 mg under fasting and fed conditions. Subjects were given naltrexone 50 mg to limit opioid effects. Plasma concentrations of morphine and its active metabolite morphine-6-glucuronide (M6G) were obtained up to 48 h post-dose; area under the plasma concentration-time curve (AUC) from time 0 extrapolated to infinity (AUC

resultsOf 28 enrolled subjects, 27 completed all treatments; 1 subject in the fasted group withdrew voluntarily. Under fed conditions, the C

conclusionMorphine ARER can be administered without regard to food. Plain language summary available for this article.

fundingInspirion Delivery Sciences, LLC.

Indexed as

Abuse-Deterrent FormulationsAdultAnalgesics, OpioidArea Under CurveBiological AvailabilityCross-Over StudiesDelayed-Action PreparationsFastingFemaleFood-Drug InteractionsHumansMaleMorphineMorphine DerivativesNaltrexoneNarcotic AntagonistsAbuse-Deterrent FormulationsAnalgesics, OpioidDelayed-Action PreparationsMorphinemorphine-6-glucuronideMorphine DerivativesNaltrexoneNarcotic AntagonistsAbuse-deterrentMorphineOpioidPainPharmacokinetics

Identifiers

PMID31278694
PMCPMC6822839

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.