Extended-Release Viloxazine for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Non-stimulant medication therapy for children, adolescents, and young adults with attention-deficit/hyperactivity disorder (ADHD) has included alpha 2-agonists (guanfacine and clonidine) as well as a norepinephrine reuptake inhibitor (atomoxetine) for multiple years. Although these may be effective options for some children, they are generally considered to be less effective than stimulant medications. In addition, there has been a suicidal ideation concern in early-late adolescence with atomoxetine, emphasizing the need for continued development of other treatment options. Extended-release viloxazine (SPN-812) has been shown in phase 2 and phase 3 trials to be an effective, well-tolerated alternative for some children with ADHD. The mechanism of action of viloxazine is unique, modulating activity of both serotonin and norepinephrine. Treatment-related adverse events most commonly seen included somnolence, decreased appetite, and headache. Although continued evaluation to confirm the reduced symptoms of ADHD in children along with the safety profile is needed, extended-release viloxazine may offer a once-a-day pharmaceutical treatment option for patients in which stimulant medication is not effective or not a favorable option. It may also be beneficial for those children and adolescents with a comorbidity of depression.