Evidence map›Paper›PMID 33368026›Full record

Trial reportClinical drug investigation2021

Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults.

Shamia L Faison, Nicholas Fry, Toyin Adewole, Oyinkansola Odebo, Stefan Schwabe, Zhao Wang, Vladimir Maletic, Azmi Nasser

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical drug investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

14 citing papers in PubMed, 22 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

8 authors at 2 institutions in 1 country.

Shamia L FaisonSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA.
Nicholas FrySupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA.
Toyin AdewoleSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA.
Oyinkansola OdeboSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA.
Stefan SchwabeSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA.
Zhao WangSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA.
Vladimir MaleticDepartment of Psychiatry/Behavioral Science, University of South Carolina School of Medicine, Greenville, SC, USA.
Azmi NasserSupernus Pharmaceuticals, Inc., 9715 Key West Avenue, Rockville, MD, 20850, USA. anasser@supernus.com.
Supernus Pharmaceuticals (United States) · USUniversity of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesViloxazine extended-release (viloxazine ER, SPN-812) is a novel non-stimulant with activity at serotonin receptors and the norepinephrine transporter, which is under investigation as a potential treatment for attention-deficit/hyperactivity disorder. Given the potential for viloxazine ER to be coadministered with other pharmacotherapies, this trial investigated the pharmacokinetics and safety of combination viloxazine ER + methylphenidate versus viloxazine ER or methylphenidate alone.

methodsIn this single-center, crossover, open-label trial, healthy adult participants received oral administration of 700 mg viloxazine ER alone, 36 mg methylphenidate alone, and combination viloxazine ER (700 mg) + methylphenidate (36 mg), with blood samples collected over 4 days post-administration. The active drug in viloxazine ER (viloxazine) and methylphenidate was measured using chromatographic tandem mass spectrometry. Safety assessments included adverse events (AEs), vital signs, echocardiograms, and clinical laboratory evaluations.

resultsOf 36 healthy adults who were enrolled, 34 completed the trial. The geometric least squares mean ratios are reported as [combination/single drug (90% confidence intervals)]. For viloxazine ER, maximum measured plasma concentration (C

conclusionsCoadministration of viloxazine ER and methylphenidate did not impact the pharmacokinetics of viloxazine or methylphenidate relative to administration of either drug alone. The combination appeared to be safe and well tolerated.

Indexed as

Administration, OralAdultAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsCross-Over StudiesDelayed-Action PreparationsFemaleHumansMaleMethylphenidateMiddle AgedNorepinephrine Plasma Membrane Transport ProteinsViloxazineYoung AdultCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateNorepinephrine Plasma Membrane Transport ProteinsSLC6A2 protein, humanViloxazine

Identifiers

PMID33368026
PMCPMC7886742
OpenAlexW3113602892

What OpenQuestion holds

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Registered trials

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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.