Viloxazine ER for Pediatric and Adult ADHD Patients: Study Results Demonstrated Rapid Improvement in Inattention and in Hyperactivity/ Impulsivity With Greater Tolerability Advances

Viloxazine ER for Pediatric and Adult ADHD Patients: Study Results Demonstrated Rapid Improvement in Inattention and in Hyperactivity/ Impulsivity With Greater Tolerability

In this real-world study comparing viloxazine extended-release (ER) with atomoxetine for pediatric and adult attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older, viloxazine ER demonstrated greater improvement in total ADHD symptoms in both children and adults and in inattention and hyperactivity/impulsivity. Additionally, viloxazine ER displayed more rapid onset of action and greater tolerability than atomoxetine. 

Patients treated with viloxazine ER had greater improvements in the total ADHD-RS-5 mean score from baseline (40.3 ± 10.3 to 13.9 ± 10.2), and in inattention (t = -8.57; p<0.00001) and in hyperactivity/impulsivity (t = -9.87; p<0.00001), than those treated with atomoxetine (33.1 ± 12.1). Greater improvements in the total AISRS mean score from baseline were also shown in those treated with viloxazine ER (37.3 ± 11.8 to 11.9 ± 9.4) in inattention (t = -3.50; p<0.004) and in hyperactivity/impulsivity (t= -3.90; p<0.002) than in those treated with atomoxetine (28.8 ± 14.9). Eighty-nine percent of children and 87% of adults treated with viloxazine ER reported a positive response by 2 weeks versus 14% and 13% treated with atomoxetine, respectively. 

This open-label, unblinded, retrospective study evaluated the efficacy and tolerability of viloxazine ER as an alternative treatment for ADHD in 35 pediatric patients and 15 adult patients at outpatient psychiatric centers who had an inadequate response or experienced adverse effects from atomoxetine. Patients were initially off both viloxazine ER and atomoxetine to set a baseline, with atomoxetine doses prior to the switch ranging between 25 mg to 100 mg, and the transition to viloxazine ER with doses from 100 mg to 600 mg (maximum of 400 mg for pediatric patients). A washout period of 5 days was instituted between medications. 

Viloxazine ER demonstrated a better tolerability profile, with 4% of patients discontinuing treatment due to side effects versus 36% discontinuing atomoxetine; a total of 96% of patients preferred viloxazine ER over atomoxetine. Patients treated with viloxazine ER did not present with the common side effects typically associated with psychostimulants, such as appetite suppression, insomnia, or exacerbation of mood disorders. 

Viloxazine ER is a serotonin-norepinephrine modulator that is thought to inhibit the reuptake of norepinephrine. Viloxazine ER is approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in adults and pediatric patients 6 years and older.  

References

Price MZ, Price RL. Extended-release viloxazine compared with atomoxetine for attention deficit hyperactivity disorder. CNS Drugs. 2023;37(7):655-660. doi:10.1007/s40263-023-01023-6

QELBREE [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; 2022.