Evidence map›Paper›PMID 28350572›Full record

ArticleJournal of clinical psychopharmacology2017

Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.

Marjie L Hard, Richard J Mills, Brian M Sadler, Ryan Z Turncliff, Leslie Citrome

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Journal of clinical psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% of its field
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.

NCT01469039 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia

TypeinterventionalSponsorAlkermes, Inc.Ran2011 to 2014Enrolled623ConditionsSchizophreniaArmsALKS 9072, Placebo
NCT01493726 phase1completednot on this map

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

TypeinterventionalSponsorAlkermes, Inc.Ran2011 to 2013Enrolled88ConditionsSchizophreniaArmsALKS 9072, Low dose, ALKS 9072, Med dose, ALKS 9072, High dose, Placebo
NCT01626456 phase3completednot on this map

A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

TypeinterventionalSponsorAlkermes, Inc.Ran2012 to 2015Enrolled478ConditionsSchizophreniaArmsALKS 9072, Low, ALKS 9072, High
NCT02320032 phase1completednot on this map

A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

TypeinterventionalSponsorAlkermes, Inc.Ran2014 to 2016Enrolled140ConditionsSchizophreniaArmsAripiprazole Lauroxil
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021
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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 at 1 institution in 1 country.

Marjie L HardFrom *Alkermes, Inc, Waltham, MA; †ICON plc, Marlow, United Kingdom; ‡ICON, Gaithersburg, MD; and §the Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY.
Richard J Mills
Brian M Sadler
Ryan Z Turncliff
Leslie Citrome
New York Medical College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAripiprazole lauroxil is an extended-release prodrug of aripiprazole for intramuscular injection, approved for schizophrenia treatment. We developed a population pharmacokinetic (PopPK) model to characterize aripiprazole lauroxil PK and evaluate dosing scenarios likely to be encountered in clinical practice.

methodsData from 616 patients with schizophrenia, collected from 5 clinical studies, were used to construct the PopPK model. The model was subsequently used to evaluate various dose levels and frequency and the impact of dosing delay on aripiprazole concentrations.

findingsThe results of the model indicate that aripiprazole is released into the systemic circulation after 5 to 6 days, and release continues for an additional 36 days. The slow increase in aripiprazole concentration after injection necessitates the coadministration of oral aripiprazole for 21 days with the first injection. Based on the PopPK model simulations, a dosing interval of 882 mg every 6 weeks results in aripiprazole concentrations that fall within the concentration range associated with the efficacious aripiprazole lauroxil dose range (441-882 mg dosed monthly). A 662-mg monthly dose also resulted in aripiprazole concentrations within the efficacious dose range. Aripiprazole lauroxil administration results in prolonged exposure, such that dose delays of 2 to 4 weeks, depending on the dose regimen, do not require oral aripiprazole supplementation upon resumption of dosing.

conclusionsThis PopPK model and model-based simulations were effective means for evaluating aripiprazole lauroxil dosing regimens and management of missed doses. Such analyses play an important role in determining the use of this long-acting antipsychotic in clinical practice.

Indexed as

Antipsychotic AgentsAripiprazoleClinical Trials as TopicDelayed-Action PreparationsHumansInjections, IntramuscularModels, TheoreticalSchizophreniaAntipsychotic AgentsAripiprazolearipiprazole lauroxilDelayed-Action Preparations

Identifiers

PMID28350572
PMCPMC5400404
OpenAlexW2599566543

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.