Viloxazine extended-release capsules for the treatment of attention-deficit/ hyperactivity disorder in adult patients

ABSTRACT

Introduction

Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with symptoms that may persist in up to 90% of adults diagnosed during childhood and continue to cause significant impairment throughout the lifespan. In the United States (US), amphetamine and methylphenidate formulations have been available to treat ADHD for several decades. Only one nonstimulant, atomoxetine, was available for the treatment of ADHD in adults until recently. In April 2022, a second nonstimulant, viloxazine extended-release (VLX-ER), became available in the US for the treatment of adult ADHD. Efficacy was previously established in placebo-controlled trials in children and adolescents.

Areas covered

VLX-ER is a norepinephrine reuptake inhibitor with serotonin activity. The efficacy in adults, adverse event profile, pharmacokinetics, drug–drug interactions, and metabolism of VLX-ER are reviewed.

Expert opinion

Despite the availability of effective pharmacological treatments for ADHD, many patients discontinue treatment in less than 1 year. Stimulants are effective in more than 80% of patients; however, some may have difficulty tolerating them. Although there were no head-to-head studies, the effect size of VLX-ER in an adult efficacy trial was lower than has been shown for stimulants. Nevertheless, the approval of VLX-ER adds another effective ADHD treatment option for adults.

KEYWORDS:

• ADHD
• attention-deficit/hyperactivity disorder
• nonstimulant
• norepinephrine reuptake inhibitor
• viloxazine extended-release

Article highlights

• Viloxazine ER is a novel norepinephrine reuptake inhibitor and serotonin modulator that is FDA approved for the treatment of ADHD in children, adolescents, and adults in the US.

• Viloxazine ER can be safely administered concomitantly with amphetamine or methylphenidate; no significant pharmacokinetic interactions were found when administered together in healthy adults.

• Viloxazine ER is available as a capsule that can be opened and sprinkled on soft foods, providing a nonstimulant treatment option for patients who are unable to swallow tablets or capsules.

• Viloxazine ER can fill a market need for adult patients who choose not to take stimulants, are non-responsive to stimulants or have contraindications to treatment with stimulants.

• Future research should evaluate the efficacy of Viloxazine ER in comorbid ADHD and depression.

Declaration of interest

A Childress received research support, served on an advisory board, as a consultant or speaker or has received writing support from the following: Aardvark, Acadia, Adlon, Akili, Allergan, Attentive, Axial, Cingulate, Corium, Emalex, Ironshore, Kempharm Lumos, Neurocentria, Noven, Otsuka, Purdue, Receptor Life Sciences, Sunovion, Supernus, Takeda, Tris and Tulex in the past 3 years. 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 paper was not funded.