OBJECTIVES: The novel non-stimulant Viloxazine ER (VLX; Qelbree®) received FDA approval for the treatment of pediatric (ages 6-17) ADHD in 2021 and adult ADHD in 2022. Limited real-world data exist on patients who fill newly approved ADHD medications. This study analyzes baseline healthcare utilization and demographic characteristics of ADHD patients who filled FDA-approved medications post-VLX introduction.

METHODS: All available Kythera open claims data were used for the analysis of patients aged ≥ 6 years with a documented ADHD diagnosis (ICD-10: F90.x), who received an initial prescription for VLX, atomoxetine (ATX; Strattera®), stimulant monotherapies, or their combinations for over 60 days in the selection period (pediatrics: 01Oct2021-31Aug2022; adults: 01Aug2022-30Nov2022). Patient characteristics were evaluated across the five treatment arms using non-parametric tests for continuous and categorical variables.

RESULTS: The patient cohort included 216,184 children (ages 6-11 years), 252,780 adolescents (ages 12-17), and 577,882 adults (ages ≥18). Approximately 95% of patients across all age groups were prescribed stimulant monotherapy. Patients on VLX regimens tended to be younger and exhibit higher psychiatric complexity. Presence of psychiatric comorbidities (anxiety, conduct, autism, and depression) differed significantly for children prescribed VLX regimens (31.2%), ATX regimens (22.9%) and stimulants (15.2%), p<0.01. At baseline, VLX regimens in children were more often co-prescribed second-generation antipsychotics (18.1% vs 13.8% vs 6.5%, p<0.01) and SSRIs (16.5% vs 13.7% vs 8.3%, p<0.01) than ATX regimens and stimulant groups, respectively.

CONCLUSIONS: Across all age groups, patients filling prescriptions for novel VLX regimens tended to be younger and have more psychiatric diagnoses than those filling prescriptions for ATX regimens or stimulants. Further research is needed to determine whether the greater psychiatric complexity in patients receiving prescriptions for VLX regimens results from its recent market entry or prescription step-therapy rules; however, these demographic factors are important to consider in outcomes analyses.