Viloxazine ER treatment was associated with symptom, function, and clinical improvement in adults with attention deficit hyperactivity disorder.
Nine out of 10 children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) continue to experience symptoms into adulthood. ADHD can negatively affect educational status, social isolation, sleep disturbances, and self-esteem. Receiving ADHD treatment can 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 non-stimulant ADHD medication inhibits the reuptake of noradrenaline with possible serotonergic effects.
Qelbree reaches steady-state plasma concentration after 2 days of once-daily oral dosing. The median time to peak plasma concentration is approximately 5 hours, ranging from 3 to 9 hours, after a single 200 mg dose.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 at weekly intervals in increments of 100 mg up to the maximum recommended dose of 400 mg once daily. Persons 12 to 17 years of age should start treatment with 200 mg orally once daily.
The dose can be increased by 200 mg after one week of treatment to the maximum recommended dose of 400 mg once daily. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30ml/min/1.73m2) should be initiated at 100 mg once daily, with titrations in increments of 50 to 100 mg at weekly intervals up to the maximum recommended dose of 200 mg once daily. No dose adjustment is necessary for patients with mild to moderate renal impairment (eGFR, 30-89 ml/min/1.73 m22). Dose titrations should be based on patient response and tolerability.
The benefits of viloxazine include a drug with flexible dosing and a favorable pharmacokinetic profile. Patients can take viloxazine concomitantly with ADHD stimulant medications and/or cytochrome P450 2D6 inhibitors, such as paroxetine, without worrying about drug interactions.
A team of researchers evaluated the efficacy of viloxazine ER capsules for treating ADHD in adults in a study published in the July 2022 issue of CNS drugs.2 The phase 3, double-blind, placebo-controlled study randomized 374 adults with ADHD, ages 18-65 years, to a 1:1 ratio of viloxazine ER (200-600 mg/day) or placebo for 6 weeks.
The primary efficacy endpoint was change in baseline and end-of-study scores as 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 to study end was greatest in the viloxazine ER treatment group for AISRS total scores, CGI-S, CGI-I , and KORT-A. Adults in the viloxazine ER group had a 30% higher AISRS response compared to placebo.
Differences in GAD-7 scores were not clinically significant. The viloxazine ER group had clinically significant score improvements at 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 those of Phase 3 studies in children and adolescents.
About the author
Sarah Meade is a 2023 PharmD candidate at the University of Connecticut.
1. Holmberg, M. Qelbree of 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 study evaluating 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]