Viloxazine ER Shows Promising Outcomes for Adult Patients with ADHD

Nine of 10 children diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to experience symptoms in adulthood. ADHD may negatively impact educational status, social isolation, sleep disturbances, and self-esteem. Receiving ADHD treatment may improve some of the symptoms and improve quality of life.

In 2021, the FDA approved extended release (ER) viloxazine (Qelbree) for children and adolescents with ADHD. The nonstimulant ADHD medication inhibits norepinephrine reuptake with potential serotonergic effects.

Qelbree achieves steady-state plasma concentration after 2 days of once-daily oral administration. The median time to peak plasma concentration is approximately 5 hours, with a range of 3 to 9 hours, after a single dose of 200 mg.¹

The recommended starting dose of Qelbree is 100 mg orally, once daily for patients 6 to 11 years of age. The dose may be titrated in 100-mg increments at weekly intervals to the maximum recommended dose of 400 mg, once daily. Individuals 12 to 17 years of age should begin treatment with 200 mg orally, once daily.

The dose may be increased by 200 mg after a week of treatment to the maximum recommended dose of 400 mg, once daily. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²) should initiate treatment with 100 mg, once daily, with titrations in 50- to 100-mg increments at weekly intervals to the maximum recommended dose of 200 mg, once daily. A dose adjustment is not required for patients with mild to moderate renal impairment (eGFR, 30-89 mL/min/1.73m²). Dose titrations should be based on patient response and tolerability.

The benefits of viloxazine include a flexible-dose drug and a favorable pharmacokinetic profile. Patients can take viloxazine concomitantly with stimulant ADHD medications and/or cytochrome P450 2D6 inhibitors, such as paroxetine, without concern for drug interactions.

A team of researchers evaluated the efficacy of viloxazine ER capsules for adult ADHD treatment in a study published in the July 2022 issue of CNS Drugs.² The phase 3, double-blind, placebo-controlled trial randomized 374 adults with ADHD, aged 18-65 years, in a 1:1 ratio of viloxazine ER (200-600 mg/day) or placebo for 6 weeks.

The primary efficacy endpoint was the change in baseline and end-of study scores, determined by the Adult ADHD Investigator Symptom Rating Scale (AISRS). Other outcome measures included changes in Clinical Global Impressions-Severity of Illness (CGI-S) scores, the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A), the Generalized Anxiety Disorder-7 Item (GAD-7), and the Clinical Global Impressions Improvement (CGI-I).

Subjects underwent safety and efficacy evaluations at weeks 1, 2, 3, 4, and 6. The improvement from baseline until the end of the study was greatest in the viloxazine ER treatment group for AISRS total scores, CGI-S, CGI-I, and BRIEF-A. Adults in the viloxazine ER group had a 30% higher AISRS response rate compared to placebo.

Differences in GAD-7 scores were clinically insignificant. The viloxazine ER group had clinically significant score improvements by week 2 of treatment.

Viloxazine ER treatment was associated with symptom, function, and clinical improvement in adults with ADHD. Adults had similar safety and tolerability profiles for viloxazine ER to that of phase 3 studies in children and adolescents.

About the Author

Sarah Meade is a 2023 PharmD candidate at the University of Connecticut.

References

1. Holmberg, M. Qelbree From Supernus Pharmaceuticals, Inc. Pharmacy Times. August 17, 2021. https://www.pharmacytimes.com/view/qelbree-from-supernus-pharmaceuticals-inc
2. Nasser A, Hull J, Chaturvedi S et al. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2022 Jul 27. doi: 10.1007/s40263-022-00938-w. [Epub ahead of print]