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Viloxazine: Pediatric First Approval.

Yvette N Lamb¹

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

Paediatric Drugs

|May 26, 2021

Summary

This summary is machine-generated.

Viloxazine, a novel non-stimulant medication, is now approved for treating attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This selective norepinephrine reuptake inhibitor offers a new treatment option for pediatric ADHD patients.

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Area of Science:

Pharmacology and Psychiatry
Neuroscience
Pediatric Medicine

Background:

Viloxazine is a selective norepinephrine reuptake inhibitor.
It is a novel formulation previously marketed for adult depression in Europe.
It is developed as a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD).

Purpose of the Study:

To summarize the development milestones of viloxazine.
To highlight the first pediatric approval for ADHD treatment.

Main Methods:

Review of clinical trial data.
Summary of regulatory approval process.

Main Results:

Viloxazine received US pediatric approval in April 2021 for ADHD in patients aged 6-17 years.
Phase III trials demonstrated improvement in ADHD symptom severity.
Viloxazine is administered orally as extended-release capsules once daily.

Conclusions:

Viloxazine represents a significant advancement in non-stimulant ADHD treatment for pediatric populations.
The drug's development journey culminated in a crucial FDA approval for childhood ADHD.