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.
Although the mechanism of action of Qelbree in the treatment of ADHD is unclear, it is believed to be due to inhibition of norepinephrine reuptake. The efficacy and safety of Qelbree were based on data from an extensive development program that included four Phase 3 studies involving more than 1,000 patients 6 to 17 years of age with ADHD. The most common side effects were somnolence, loss of appetite, fatigue, nausea, vomiting, insomnia and irritability.
Due to an increased risk of hypertensive crisis, Qelbree is contraindicated in patients on concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuation of an MAO inhibitor. It must 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 has 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.
In addition, increases in heart rate and blood pressure were reported in Qelbree-treated patients in clinical studies. It is recommended to measure heart rate and blood pressure before initiation of treatment, after dose increases and periodically during treatment.
Qelbree comes as extended-release capsules of 100 mg, 150 mg, or 200 mg in bottles of 30, 60, 90 and 100 pieces. The capsules can be swallowed whole or opened and the contents mixed with applesauce.
“As an uncontrolled substance with a unique profile of proven efficacy, safety and tolerability, Qelbree offers patients with ADHD a new treatment option like no other ADHD drug,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. The company plans to file an additional new drug filing with the FDA in the third quarter of 2021 for an adult ADHD indication.
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.