Viloxazine extended-release capsules as an emerging treatment for attention-deficit/hyperactivity disorder in children and adolescents

ABSTRACT

Introduction

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention and/or hyperactivity and impulsivity. Viloxazine extended-release (ER) capsules (Qelbree®) is a US Food and Drug Administration–approved nonstimulant treatment option for children, adolescents, and adults with ADHD.

Areas covered

This review manuscript summarizes the neurobiology of ADHD and currently available treatment options before discussing viloxazine pharmacology, efficacy, safety, and tolerability data from phase II and III trials in children and adolescents (6–17 years old). Viloxazine clinical efficacy has also been further demonstrated by post hoc analyses of pediatric clinical trial results.

Expert opinion

Current stimulant and nonstimulant treatments for ADHD may be suboptimal given low response rates and that tolerability issues are frequently experienced. Preclinical and clinical evidence has implicated both the role of catecholamine and serotonin signaling in the pathophysiology of ADHD and the pharmacologic effect of viloxazine on these critical neurotransmitter systems. With a relatively rapid onset of action, sustained symptom improvement, and clinical benefit in ADHD-associated impairments (functional and social), viloxazine ER represents a novel and emerging ADHD treatment option.

KEYWORDS:

• ADHD
• attention-deficit/hyperactivity disorder
• Qelbree
• SPN-812
• viloxazine

Article highlights

• Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that affects approximately 9.4% to 10.5% of children in the US and is characterized by inattention, hyperactivity, and impulsivity.

• Current pharmacologic treatment options include stimulant and nonstimulant agents, yet some individuals experience suboptimal symptom improvement and/or tolerability issues.

• Viloxazine extended-release (ER) capsules (Qelbree®) represents an emerging, once-daily, US Food and Drug Administration–approved, nonstimulant treatment option for children and adolescents (6–17 years old) with ADHD.

• Randomized, placebo-controlled, phase II and III clinical trials demonstrated efficacy and safety in pediatric populations. ADHD symptom improvement was rapid and was maintained during subsequent open-label treatment.

• Although head-to-head data with other available agents for ADHD are lacking, post hoc analyses of pediatric clinical trial data further demonstrate the pharmacologic utility of viloxazine ER as an ADHD treatment option.

Declaration of interest

J Earnest is an employee of Supernus Pharmaceuticals. V Maletic is a consultant for Acadia Pharmaceuticals; Alfasigma U.S.A.; Alkermes; Allergan; Biogen; Boehringer Ingelheim; Cerevel Therapeutics; Corium; Eisai-Purdue; Intra-Cellular Therapies; Janssen Pharmaceuticals; Liva/Nova; Lundbeck; Neumora; Neurelis; Noven; Otsuka America Pharmaceutical; Pax Medica; Relmada; Sage Therapeutics Inc.; Sunovion; Supernus Pharmaceuticals, Inc.; and Takeda. He serves on the speakers’ bureau of AbbVie; Alfasigma; Alkermes; Allergan; Axsome; Corium; Ironshore; Intra-Cellular Therapies; Janssen; Lundbeck; Otsuka America Pharmaceutical; Sunovion, Supernus Pharmaceuticals Inc.; and Takeda. His spouse serves on the speakers’ bureau of Otsuka America Pharmaceutical. GW Mattingly has served as a consultant to Akili; Alkermes; Allergan (now AbbVie); Axsome, Intra-Cellular Therapies; Ironshore; Janssen; Lundbeck; Neos Therapeutics; Otsuka America Pharmaceutical; Purdue; Rhodes; Sage Therapeutics, Inc.; Sunovion; Takeda; and Teva. He has received research grants from Akili; Alkermes; Allergan (now AbbVie); Axsome; Boehringer Ingelheim; Janssen Pharmaceuticals; Lundbeck; Medgenics; NLS-1 Pharma (now NLS Pharmaceuticals); Otsuka America Pharmaceutical; Reckitt Benckiser; Roche; Sage Therapeutics, Inc.; Sunovion; Supernus Pharmaceuticals Inc.; Takeda; and Teva. He has received speaker/promotional honoraria from Alkermes; Allergan (now AbbVie); Ironshore; Janssen Pharmaceuticals; Lundbeck; Otsuka America Pharmaceutical; Sunovion; and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This manuscript was funded by Supernus Pharmaceuticals.