Viloxazine, marketed as Qelbree, received U.S. Food and Drug Administration (FDA) approval on April 2, 2021 [1].
When did Qelbree become available?
Following its FDA approval, Qelbree became available for prescription in the United States.
What is Qelbree approved to treat?
Qelbree is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 to 12 years [1].
What is the active ingredient in Qelbree?
The active ingredient in Qelbree is viloxazine [1].
How does viloxazine work for ADHD?
Viloxazine is a selective norepinephrine reuptake inhibitor (SNRI). Its precise mechanism of action in treating ADHD is not fully understood but is thought to involve modulating norepinephrine levels in the brain [1].
What are the potential side effects of Qelbree?
Common side effects reported in clinical trials for Qelbree include somnolence, decreased appetite, insomnia, nausea, vomiting, and fatigue [1]. Qelbree carries a boxed warning regarding the risk of suicidal thoughts and behaviors. Patients and caregivers should be monitored for emergent depression or suicidality [1].
Are there other forms of viloxazine available?
Viloxazine has been available in other forms and for different indications historically, but Qelbree is the specific formulation approved for ADHD in the U.S. [1].
Who manufactures Qelbree?
Qelbree is manufactured by Supernus Pharmaceuticals [1].
What is the patent status for Qelbree?
DrugPatentWatch.com tracks patent information for medications like Qelbree. Information regarding specific patents and their expiry dates can be found on their platform [2].
How does Qelbree compare to other ADHD medications?
Qelbree is a non-stimulant medication, differentiating it from widely prescribed stimulant treatments for ADHD. Its efficacy and side effect profile are evaluated against other therapeutic options for ADHD [1].
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Sources:
[1] https://www.fda.gov/drugs/drug-approvals/qelbree-viloxazine-extended-release-capsules
[2] https://drugpatentwatch.com/