Comparison of ADHD Treatment in Males and Females: Post-hoc Analysis of Baseline Presentation and Viloxazine ER Treatment Efficacy Data Stratified by Sex

OBJECTIVE: Historically, girls and women have been thought to have milder cases of ADHD and present with predominantly inattentive ADHD symptoms. This post-hoc analysis of viloxazine ER clinical trials evaluated baseline presentation and treatment efficacy, stratified by sex.
METHODS: We evaluated 1 adult and 4 pooled pediatric double-blind, placebo-controlled (DBPC) trials conducted to support the US FDA approvals of viloxazine ER for ADHD, and the ensuing open-label safety trials.
RESULTS: Similar percentages of males and females were enrolled in the adult trials (DBPC n=372, 45% female; OLE n=159, 48% female), while the pediatric trials enrolled a higher percentage of males (DBPC n=1604, 35% female; OLE n=1100, 34% female). Males and females showed similar baseline severity in both the adult (AISRS: 37.7±6.77 (mean±SD) and 39.6±6.16, respectively) and pediatric (ADHD-RS-V: 42.8±7.43 and 42.1±7.50) DBPC trials, and similar changes with treatment at week 6 (AISRS: -15.4±1.25 (LS mean±SE) and -15.9±1.52, respectively; ADHD-RS-V: -17.0±0.56 and -17.2±0.77). Males and females also showed similar baseline severity in Inattention subscale (adults: 20.8±3.53 and 22.5±3.32; pediatric: 22.6±3.52 and 22.3±3.54) and Hyperactivity/Impulsivity subscale scores (adults: 16.9 ±5.00 and 17.1±5.08; pediatric: 20.2±5.60 and 19.7± 5.42). All scores showed similar improvement in the DBPC trials and throughout the OLE studies up to 1 year in adults and 3 years in children and adolescents.
CONCLUSIONS: Similar baseline severity in symptoms was observed in females vs. males. Notably, for both the adult and pediatric populations, females were as likely as males to have combined symptoms, with similar improvement upon viloxazine ER treatment.