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Nasser A, Gomeni R, Wang Z, et al. Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder. J Clin Pharmacol. 2021;61(12):1626-1637doi: 10.1002/jcph.1940.
Nasser, A., Gomeni, R., Wang, Z., Kosheleff, A. R., Xie, L., Adeojo, L. W., & Schwabe, S. (2021). Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder. Journal of clinical pharmacology, 61(12), 1626-1637. https://doi.org/10.1002/jcph.1940
Nasser, Azmi, et al. "Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder." Journal of clinical pharmacology vol. 61,12 (2021): 1626-1637. doi: https://doi.org/10.1002/jcph.1940
Nasser A, Gomeni R, Wang Z, Kosheleff AR, Xie L, Adeojo LW, Schwabe S. Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder. J Clin Pharmacol. 2021 Dec;61(12):1626-1637. doi: 10.1002/jcph.1940. Epub 2021 Aug 08. PMID: 34269426.
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J Clin Pharmacol. 2021 Dec;61(12):1626-1637. doi: 10.1002/jcph.1940. Epub 2021 Aug 08.

Population Pharmacokinetics of Viloxazine Extended-Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder.

Journal of clinical pharmacology

Azmi Nasser, Roberto Gomeni, Zhao Wang, Alisa R Kosheleff, Lanyi Xie, Lilian W Adeojo, Stefan Schwabe

Affiliations

  1. Supernus Pharmaceuticals Inc., Rockville, Maryland, USA.
  2. Pharmacometrica, Lieu-dit Longcol, La Fouillade, France.

PMID: 34269426 DOI: 10.1002/jcph.1940

Abstract

Viloxazine extended-release capsules (viloxazine ER; Qelbree) is a novel nonstimulant, recently approved by the US Food and Drug Administration for the treatment of ADHD in pediatrics. Here, we characterize the pharmacokinetics (PK) of viloxazine and its major metabolite, 5-HVLX-gluc, using a population PK model and evaluate the impact of 1-4 days of missed viloxazine ER doses on viloxazine PK. Data from 4 phase 3 trials in pediatric subjects treated with viloxazine ER were used to establish the PK model. Covariate analysis was conducted on the final base model. The impact of 1-4 days of missed doses on steady-state viloxazine PK was evaluated using Monte Carlo simulations. A 1-compartmental linear model with first-order absorption and elimination of the parent drug and first-order metabolite formation and elimination properly described the population PK of viloxazine and 5-HVLX-gluc. Body weight impacted the systemic exposure of viloxazine and 5-HVLX-gluc. Predicted PK parameters at steady state (mean ± standard deviation) in children receiving viloxazine ER were determined. C

© 2021 Supernus Pharmaceuticals, Inc. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.

Keywords: ADHD; SPN-812; drug holiday; pharmacokinetics; population PK; viloxazine

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