EFFICACY OF LONG-TERM TREATMENT WITH VILOXAZINE EXTENDED-RELEASE CAPSULES (QELBREE™) IN CHILDREN AND ADOLESCENTS WITH ADHD: AN OPEN-LABEL EXTENSION STUDY

Abstract

Viloxazine extended-release capsules (viloxazine ER; Qelbree™) is a novel nonstimulant recently approved for the treatment of ADHD in children and adolescents based on results from 3 pivotal Phase 3 trials. Here, we report efficacy results of the ADHD Rating Scale, 5th Edition (ADHD-RS-5) and Clinical Global Impression-Improvement (CGI-I) assessed during the long-term open-label extension (OLE) safety study of viloxazine ER. The change from baseline (pivotal; CFB) in ADHD-RS-5 Total score, 50% ADHD-RS-5 Responder Rate (percentage of subjects with a ≥50% reduction in their CFB ADHD-RS-5 Total score), and CGI-I Responder Rate (percentage of subjects with a CGI-I score of 1 or 2) were analyzed by visit from pivotal to last visit in an OLE trial. Subjects were grouped based on pivotal trial treatment assignment (pivotal-placebo or pivotal-viloxazine ER). In the OLE trial, subjects aged 6-11 years were dosed at 100 mg/day or titrated up (100 mg/day/week) to optimal dose at or below 400 mg/day, and subjects aged 12-17 years were dosed at 100 mg/day or titrated up (100 or 200 mg/day/week) to optimal dose at or below 600 mg/day. Of the 1170 subjects who completed a pivotal trial, 1100 subjects were dosed in the OLE (323 pivotal-placebo and 777 pivotal-viloxazine ER). The median dose of viloxazine ER was 300 mg in children aged 6-11 years and 400 mg in adolescents aged 12-17 years. ADHD symptoms improved in the first month and continued improving over time during OLE in both pivotal-placebo and pivotal-viloxazine ER subjects. The mean (±SD) CFB in ADHD-RS-5 Total score at last visit during OLE was significantly improved in the pivotal-viloxazine ER group (–19.3 ± 13.22; p < 0.0001) and in the pivotal-placebo group (–18.0 ± 13.17; p < 0.0001). For both groups, ADHD-RS-5 and CGI-I responder rates were above 50% within the first 3 months, remained above 65% after 3 months, and remained above 75% after 18 months of treatment. ADHD symptoms significantly improved and the number of subjects experiencing a clinically meaningful improvement increased over time during long-term viloxazine ER treatment. These data indicate that viloxazine ER treatment can provide sustained efficacy, further improve ADHD symptoms, and increase the responder rates even after 8 weeks of treatment.