Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Jul;23(4):403-409.
doi: 10.1007/s40272-021-00453-3.

Viloxazine: Pediatric First Approval

Yvette N Lamb  1
Affiliations
Review

Viloxazine: Pediatric First Approval

Yvette N Lamb. Paediatr Drugs. 2021 Jul.

Erratum in

Abstract

Viloxazine (QELBREE™), a selective norepinephrine reuptake inhibitor, is being developed by Supernus Pharmaceuticals as a non-stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. This is a novel formulation of a pharmacological agent formerly marketed in Europe for the treatment of depression in adults. Viloxazine received its first pediatric approval in April 2021 in the USA for the treatment of ADHD in pediatric patients aged 6-17 years. Approval was based on positive results from a series of short-term phase III clinical trials in which viloxazine improved the severity of ADHD symptoms in children and adolescents with diagnosed ADHD. Viloxazine is available as extended-release capsules for once-daily oral administration. This article summarizes the milestones in the development of viloxazine leading to this first pediatric approval for ADHD.

PubMed Disclaimer

Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yvette Nicole Lamb is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

None
Key milestones in the development of viloxazine, focusing on its use in the treatment of pediatric pts with ADHD. ADHD attention-deficit/hyperactivity disorder, CRL Complete Response Letter, NDA New Drug Application, pts patients
None
Viloxazine chemical structure
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Supernus Pharmaceuticals. Supernus announces issuance of first use patents protecting SPN-812 as a novel non-stimulant ADHD product [media release]. 2014. http://www.supernus.com.
    1. Yu C, Garcia-Olivares J, Candler S, et al. New insights into the mechanism of action of viloxazine: serotonin and norepinephrine modulating properties. J Exp Pharmacol. 2020;12:285–300. doi: 10.2147/JEP.S256586. - DOI - PMC - PubMed
    1. Faison SL, Fry N, Adewole T, et al. Pharmacokinetics of coadministered viloxazine extended-release (SPN-812) and lisdexamfetamine in healthy adults. J Clin Psychopharmacol. 2021;41(2):155–162. doi: 10.1097/JCP.0000000000001361. - DOI - PMC - PubMed
    1. Pozzi M, Bertella S, Gatti E, et al. Emerging drugs for the treatment of attention-deficit hyperactivity disorder (ADHD) Expert Opin Emerg Drugs. 2020;25(4):395–407. doi: 10.1080/14728214.2020.1820481. - DOI - PubMed
    1. Cutler AJ, Mattingly GW, Jain R, et al. Current and future nonstimulants in the treatment of pediatric ADHD: monoamine reuptake inhibitors, receptor modulators, and multimodal agents. CNS Spectr. 2020;2020:1–9. - PubMed

MeSH terms

Substances