Qelbree (viloxazine extended-release capsules), is now available for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients 6 to 17 years of age.
While the mechanism of action of Qelbree in the treatment of ADHD is unclear, it is thought to be through inhibiting the reuptake of norepinephrine. The efficacy and safety of Qelbree were based on data from an extensive development program that included four phase 3 studies involving more than 1000 patients 6 to 17 years of age with ADHD. The most commonly observed adverse reactions were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.
Due to an increased risk of hypertensive crisis, Qelbree is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days after discontinuing an MAOI. It should also not be used in patients receiving sensitive CYP1A2 substrates (eg, clozapine, pirfenidone) or CYP1A2 substrates with a narrow therapeutic range (eg, alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline).
Qelbree carries a Boxed Warning regarding higher rates of suicidal thoughts and behavior. Before starting treatment, patients should be screened for a personal or family history of suicide, bipolar disorder, and depression.
Additionally, increases in heart rate and blood pressure were reported in Qelbree-treated patients in clinical trials. It is recommended that prior to initiating treatment, following increases in dosage, and periodically while on therapy, heart rate and blood pressure should be assessed.
Qelbree is supplied as 100mg, 150mg, or 200mg extended-release capsules in 30-, 60-, 90-, and 100-count bottles. Capsules may be swallowed whole or opened and the contents mixed with applesauce.
“As a non-controlled substance that has a unique profile of proven efficacy, safety, and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. The Company is planning to submit a supplemental New Drug Application to the FDA for an adult ADHD indication in the third quarter of 2021.
- Qelbree (viloxazine extended-release capsules), a new non-controlled substance, now available for the treatment of ADHD in pediatric patients 6-17 years of age. [press release]. Rockville, MD: Supernus Pharmaceuticals, Inc.; May 24, 2021.
- Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; 2021.