Evidence map›Paper›PMID 33943033›Full record

ArticleClinical pharmacology in drug development2021

Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN-812 (Viloxazine Extended-Release) Pharmacokinetics in Healthy Adults.

Zhao Wang, Alisa R Kosheleff, Lilian W Adeojo, Oyinkansola Odebo, Toyin Adewole, Peibing Qin, Vladimir Maletic, Stefan Schwabe, Azmi Nasser

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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 21% 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

10 citing papers in PubMed, 14 citations in OpenAlex.

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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

9 authors at 2 institutions in 1 country.

Zhao WangSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Alisa R KosheleffSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Lilian W AdeojoSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Oyinkansola OdeboSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Toyin AdewoleSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Peibing QinSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Vladimir MaleticDepartment of Psychiatry/Behavioral Science, University of South Carolina School of Medicine, Greenville, South Carolina, USA.
Stefan SchwabeSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Azmi NasserSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Supernus Pharmaceuticals (United States) · USUniversity of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

SPN-812 (viloxazine extended-release) is a novel nonstimulant recently approved as a treatment for attention-deficit/hyperactivity disorder in children and adolescents. Given that SPN-812 is metabolized by CYP2D6 and may be coadministered with CYP2D6 inhibitors, this trial investigated the pharmacokinetics and safety of SPN-812 coadministered with the potent CYP2D6 inhibitor paroxetine. In this single-sequence, 3-treatment period study in healthy volunteers, subjects received a single oral dose of 700 mg SPN-812 alone (period 1), 20 mg daily paroxetine (10 days, period 2), followed by concurrent administration of SPN-812 and paroxetine (period 3). Blood samples were collected for 72 hours post-SPN-812 dosing and analyzed for viloxazine and its primary metabolite, 5-HVLX-gluc. Twenty-two healthy adults were enrolled; all completed the trial. The potential for drug interaction between SPN-812 and paroxetine was assessed using analysis of variance on the log-transformed pharmacokinetic parameters C

Indexed as

Adrenergic Uptake InhibitorsAdultAttention Deficit Disorder with HyperactivityCytochrome P-450 CYP2D6 InhibitorsDelayed-Action PreparationsFemaleHealthy VolunteersHumansMaleMiddle AgedParoxetineViloxazineAdrenergic Uptake InhibitorsCytochrome P-450 CYP2D6 InhibitorsDelayed-Action PreparationsParoxetineViloxazineattention-deficit/hyperactivity disorderCYP2D6paroxetinepharmacokineticsSPN-812viloxazine

Identifiers

PMID33943033
PMCPMC8597116
OpenAlexW3157482248

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.