Qelbree Becomes First Non-Stimulant ADHD Medication Approved in Over a Decade

April 2, 2021 – The U.S. FDA has approved Qelbree® (viloxazine) extended-release oral capsules, manufactured by Supernus Pharmaceuticals, to treat attention deficit hyperactivity disorder (ADHD) in patients who are 6-17 years old. Qelbree is the first non-stimulant ADHD medication to receive FDA approval in more than a decade. It is also the fourth non-controlled substance ADHD drug to receive approval from the FDA.

ADHD is one of the most common neurodevelopmental disorders diagnosed in children and often persists into adulthood. Individuals who have ADHD may have difficulty controlling impulsive actions and/or focusing and may display hyperactivity (a level of activity beyond what would be considered appropriate for the situation). ADHD is split into subtypes depending on how symptoms manifest, with some patients experiencing all three characteristics of the disorder while others may predominately experience only one or two. The disorder’s impact on day-to-day life can be severe, impacting an individual’s learning, social life, self-esteem, and career. Treatment frequently involves a combination of talk therapy and medication.

In clinical trials, Qelbree showed statistically significant onset of action starting in Week 2 of treatment.

According to Supernus Pharmaceuticals, the drug may improve symptoms as early as the first week of treatment. There may also be less risk of rare liver toxicity and hypotension (low blood pressure) with Qelbree compared to other non-stimulant ADHD treatments such as Strattera® (atomoxetine HCl – Eli Lilly) and Intuniv® (guanfacine – Shire). However, a black box warning cautions that in clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients receiving Qelbree than those on placebo. Patients on Qelbree should be closely monitored for worsening and emergence of suicidal thoughts and behavior.

The recommended starting dose for patients 6-11 years old is 100mg once daily. The dose can be titrated in increments of 100mg weekly if needed to a maximum recommended dose of 400mg once daily. For patients 12-17 years old, the recommended starting dose is 200mg once daily. After one week, the dose can be increased if needed by 200mg to the maximum recommended dose of 400mg once daily. Capsules can be swallowed whole or opened and the entire contents sprinkled onto applesauce. Dose modification is required for patients who have severe renal impairment. For all patients, the dosage and long-term use of Qelbree should be reevaluated on a regular basis.

Supernus plans to launch Qelbree during the second quarter of 2021 at a wholesale acquisition cost (WAC) of $299 for 30-count of 200mg tablets.