Evidence map›Paper›PMID 33750027›Full record

ArticleClinical pharmacology in drug development2021

Evaluation of Drug-Drug Interaction Liability for Buprenorphine Extended-Release Monthly Injection Administered by Subcutaneous Route.

Jahnavi Kharidia, Eleanor M Howgate, Celine M Laffont, Yongzhen Liu, Malcolm A Young

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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.

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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Buprenorphine Use for Analgesia in Palliative Care.Pharmacy (Basel, Switzerland) · 2024
    Article
  7. Article
  8. Review
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 2 institutions in 2 countries.

Jahnavi KharidiaIndivior Inc., North Chesterfield, Virginia, USA.
Eleanor M HowgateCertara UK Limited (Simcyp Division), Sheffield, UK.
Celine M LaffontIndivior Inc., North Chesterfield, Virginia, USA.
Yongzhen LiuIndivior Inc., North Chesterfield, Virginia, USA.
Malcolm A YoungIndivior Inc., North Chesterfield, Virginia, USA.
Indivior (United States) · USSimcyp (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Buprenorphine extended-release (BUP-XR) formulation is a once-monthly subcutaneous injection for the treatment of opioid use disorder (OUD). Buprenorphine undergoes extensive cytochrome P450 (CYP) 3A4 metabolism, leading to potential drug-drug interactions (DDIs) as reported for sublingual buprenorphine. Sublingual buprenorphine is subject to first-pass extraction, as a significant proportion of the dose is swallowed. Because subcutaneous administration avoids first-pass extraction, the DDI with CYP3A4 inhibitors is expected to be less than the 2-fold increase reported for the sublingual route. The objective of this analysis was to predict the magnitude of DDI following coadministration of BUP-XR with a strong CYP3A4 inhibitor or inducer using physiologically based pharmacokinetic (PBPK) modeling. Models were developed and verified by comparing predicted and observed data for buprenorphine following intravenous and sublingual dosing. Comparison of predicted and observed pharmacokinetic (PK) profiles and PK parameters demonstrated acceptable predictive performance of the models (within 1.5-fold). Buprenorphine plasma concentrations following administration of a single dose of BUP-XR (300 mg) were simulated using a series of intravenous infusions. Daily coadministration of strong CYP3A4 inhibitors with BUP-XR predicted mild increases in buprenorphine exposures (AUC, 33%-44%; C

Indexed as

Models, BiologicalAdultArea Under CurveBuprenorphineCytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsDelayed-Action PreparationsDrug InteractionsFemaleHumansInjections, SubcutaneousMaleMiddle AgedNarcotic AntagonistsYoung AdultBuprenorphineCytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsDelayed-Action PreparationsNarcotic Antagonistsbuprenorphine extended releaseCYP3A4drug-drug interactionopioid use disorderphysiologically based pharmacokinetic model

Identifiers

PMID33750027
PMCPMC8451859
OpenAlexW3138862626

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.