A critical review of the dextroamphetamine transdermal system for the treatment of ADHD in adults and pediatric patients

ABSTRACT

Introduction

The dextroamphetamine transdermal system (d-ATS) is a stimulant patch recently approved by the United States (U.S.) Food and Drug Administration for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Areas covered

The composition of the d-ATS, pharmacokinetics, and metabolism are presented along with data from dermal trials evaluating the tolerability of patch application at various skin sites. Efficacy and safety data from a laboratory classroom study in children and adolescents including effect sizes are assessed. Pharmacokinetic-pharmacodynamic modeling of variable wear times is also discussed.

Expert opinion

Although stimulants are recommended as first-line treatment for ADHD in the U.S. some patients may have difficulty swallowing intact tablets and capsules, or dislike the taste or texture of chewable, oral disintegrating, or liquid formulations. The d-ATS fills an unmet need for those with ADHD who are unable or prefer not to take medication orally. Varying wear time of the d-ATS also gives flexibility in length of stimulant effect which may be useful for patients with changing schedules. However, dermal discomfort must be considered in addition to the usual amphetamine side effects when prescribing the d-ATS. Patient and provider experience will determine how frequent the use of d-ATS becomes.

KEYWORDS:

• ADHD
• amphetamine
• attention-deficit/hyperactivity disorder
• d-amphetamine transdermal system
• stimulant

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Correction

Article highlights

• The dextroamphetamine Transdermal system (d-ATS) has been approved by the United States Food and Drug Administration (FDA) to treat ADHD in patients aged 6 years and older.

• The d-ATS can be applied to multiple skin sites and provides efficacy for 12 hours when worn for 9 hours.

• The Effect size for the d-ATS compared to placebo using the ADHD Rating Scale-IV was 1.1.

• Total exposure and maximum concentration were dose-proportional over the doses from 4.5 mg/9 hours to 18 mg/9 hours after a single administration.

• The most common adverse events (greater than 2% and greater than placebo) reported during a double-blind clinical trial were decreased appetite, insomnia, headache, affect lability, vomiting, abdominal pain, and nausea.

• Application site reactions included severe discomfort in 10% of subjects and skin irritation observed in 94% of subjects during clinic assessments.

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 over the past 36 months. 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.

Correction Statement

This article was originally published with errors, which have now been corrected in the online version. Please see Correction (http://dx.doi.org/10.1080/14737175.2024.2356442)

Additional information

Funding

This manuscript was not funded.