FOR US HEALTH CARE PROFESSIONALS ONLY
Supernus Medical Affairs LogoMenu Toggle
FIND AN MSLArrow RightSUBMIT AN INQUIRYArrow Right
Back to posters

BACK TO CONGRESS POSTERS

INTERACT WITH THE DATA

Viloxazine ER Administered with Psychostimulants in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results of a Phase IV Safety Trial.

Childress A, Hayman K, Asubonteng K, Yarullina I, Earnest J, Rubin J.

Presented at American Association of Psychiatric Pharmacists (AAPP) 2024

STUDY DESIGN

An open-label, flexible-dose, safety and efficacy study of viloxazine ER in pediatric patients with ADHD experiencing suboptimal* efficacy to psychostimulants.

Study Design BannerINDICATES AN INTERACTIVE ELEMENT

Viloxazine ER Combination Therapy AM/PM Dosing

Study Design
Study Design Banner
Study Design Banner

*IR-ADHD-RS-5 score ≥24 and a CGI-S score ≥3 (mildly ill or worse) at screening and baseline.

STUDY DESIGN

Expand Study Design

An open-label, flexible-dose, safety and efficacy study of viloxazine ER in pediatric patients with ADHD experiencing suboptimal* efficacy to psychostimulants.

Study Design BannerINDICATES AN INTERACTIVE ELEMENT

Viloxazine ER Combination Therapy AM/PM Dosing

Study Design
Study Design Banner
Study Design Banner
SCROLL TO VIEW STUDY DESIGNStudy Design Banner

*IR-ADHD-RS-5 score ≥24 and a CGI-S score ≥3 (mildly ill or worse) at screening and baseline.

STUDY RESULTS

Expand Study Design

Patient Demographics

Patient Demographics

n=56

PARTICIPANTS RECEIVED VILOXAZINE ER

Patient Demographics

85.7%

(48/56)
PARTICIPANTS COMPLETED THE STUDY

Patient Demographics

69.6%

(39/56)
MALE

Patient Demographics

30.4%

(17/56)
FEMALE

Patient Demographics

46.4%

CHILDREN
(AGED 6-11 YEARS)

Patient Demographics

53.6%

ADOLESCENTS
(AGED 12-17 YEARS)

CONCLUSIONS

Expand Study Design

The addition of viloxazine ER to ongoing stimulant treatment was safe, well tolerated, and provided enhanced efficacy in children and adolescents with ADHD.

FULL POSTER

Expand Study Design
Study Design Banner

View and download the full poster

VIEW PDFDown arrow

ADHD, attention-deficit/hyperactivity disorder; CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity of Illness; ECG, electrocardiogram; ER, extended-release; FDA, US Food and Drug Administration; IR-ADHD-RS-5, Investigator-Rated Attention-Deficit/Hyperactivity Disorder-Rating Scale-5; SAE, serious adverse event; SDSC, Sleep Disturbance Scale for Children; TEAE, treatment-emergent adverse event.

STUDY RESULTS

Patient Demographics

Patient Demographics

n=56

PARTICIPANTS RECEIVED VILOXAZINE ER

Patient Demographics

85.7%

(48/56) PARTICIPANTS COMPLETED THE STUDY

Patient Demographics

69.6%

(39/56) MALE

Patient Demographics

30.4%

(17/56) FEMALE

Patient Demographics

46.4%

CHILDREN
(AGED 6-11 YEARS)

Patient Demographics

53.6%

ADOLESCENTS
(AGED 12-17 YEARS)

CONCLUSIONS

The addition of viloxazine ER to ongoing stimulant treatment was safe, well tolerated, and provided enhanced efficacy in children and adolescents with ADHD.

FULL POSTER

Study Design Banner

View and download the full poster

VIEW PDFDown arrow

ADHD, attention-deficit/hyperactivity disorder; CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity of Illness; ECG, electrocardiogram; ER, extended-release; FDA, US Food and Drug Administration; IR-ADHD-RS-5, Investigator-Rated Attention-Deficit/Hyperactivity Disorder-Rating Scale-5; SAE, serious adverse event; SDSC, Sleep Disturbance Scale for Children; TEAE, treatment-emergent adverse event.