Expanding ADHD Pharmacology: Pipeline Highlights With Ann Childress, MD

Ann Childress, MD, provided an overview of recently US Food and Drug Administration (FDA)-approved attention-deficit hyperactivity disorder (ADHD) medications and agents in late-stage development, with additional commentary on the management of comorbid sleep disorders in patients with ADHD. Childress presented on both topics at this year’s Southern California Psychiatry meeting in Huntington Beach, California.

Childress noted that approximately 30 stimulant formulations are currently available for ADHD, making formulary navigation challenging for clinicians. She focused her discussion on agents approved by the FDA within the past 5 years, including viloxazine extended-release —a nonstimulant norepinephrine and serotonin modulator approved for ADHD in patients aged 6 years and older and in adults—extended-release amphetamine chewable tablets, serdexmethylphenidate/dexmethylphenidate (a prodrug combination), and a transdermal amphetamine patch.¹ She highlighted that the prodrug approach used in serdexmethylphenidate shares conceptual lineage with lisdexamfetamine, designed to reduce misuse potential through delayed conversion to the active moiety.

Looking ahead, Childress discussed centanafadine, a first-in-class investigational norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for ADHD currently under FDA priority review, supported by data from 4 pivotal phase 3 trials across pediatric, adolescent, and adult populations.² She also briefly described CTX-1301, an investigational extended-release dexmethylphenidate formulation featuring a trirelease profile designed to extend coverage into the late afternoon and evening.

On the topic of sleep disorders in ADHD, Childress emphasized that no medications are FDA-approved for insomnia in children or adolescents, making behavioral intervention—including structured bedtime routines and sleep hygiene guidance directed primarily at parents—the essential first-line approach. She noted that behavioral therapy alone often produces sufficient improvement to obviate the need for pharmacological intervention.

Dr Childress is a child, adolescent, and adult psychiatrist, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, Nevada, and past president of the American Professional Society of ADHD and Related Disorders.

References

1. Nasser A, Liranso T, Adewole T, et al. A phase III, randomized, placebo-controlled trial to assess the efficacy and safety of once-daily SPN-812 (viloxazine extended-release) in the treatment of attention-deficit/hyperactivity disorder in school-age children. Clin Ther. 2020;42(8):1452–1466.

2. Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults [press release]. January 27, 2026. https://www.otsuka-us.com/news/otsuka-announces-fda-acceptance-and-priority-review-new-drug-application-centanafadine