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Product

SPN-812

Aliases
100mg SPN-812, Qelbree, SPN-812 (600mg, QD), Viloxazine ER (2 other aliases)
Name
QELBREE
INN Name
viloxazine hydrochloride
FDA Approved
Yes

6 clinical trials

1 organization

2 indications

1 document

Indication
Attention-Deficit/Hyperactivity Disorder
Indication
Lactating Women
Clinical trial
A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Status: Recruiting, Estimated PCD: 2025-12-01
Clinical trial
A Phase IV, Open-Label, Decentralized Clinical Trial to Evaluate the Efficacy and Safety of Qelbree® in Adults With Attention-Deficit/Hyperactivity Disorder and Mood Symptoms
Status: Recruiting, Estimated PCD: 2025-01-01
Clinical trial
Evaluation of the Excretion of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk Following Multiple Doses of SPN-812 (600mg, QD) in Healthy Lactating Women
Status: Completed, Estimated PCD: 2023-09-20
Clinical trial
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With Attention-Deficit/Hyperactivity Disorder
Status: Completed, Estimated PCD: 2022-07-26
Clinical trial
A Phase IV, Open-Label, Flexible-Dose Safety Trial Evaluating SPN-812 Administered With Psychostimulants in Children and Adolescents (6 to 17 Years of Age) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Status: Completed, Estimated PCD: 2023-05-23
Clinical trial
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
Status: Active (not recruiting), Estimated PCD: 2025-06-01
Document
DailyMed Label: QELBREE
Organization
Supernus Pharmaceuticals, Inc.