FDA Approves New Nonstimulant ADHD Medication from Supernus Pharmaceuticals

A new nonstimulant medication for ADHD from Supernus Pharmaceuticals called Qelbree has received FDA approval for treatment of patients 6 to 17 years of age.

By Lilly Constance Verified Updated on November 9, 2021

April 7, 2021

Qelbree, a new nonstimulant medication for ADHD, has received FDA approval for treatment of attention deficit hyperactivity disorder in patients 6 to 17 years of age. Qelbree is the first nonstimulant ADHD medication to receive FDA approval for use in children in more than a decade. Intuniv was the last branded, non-scheduled ADHD medication to be approved by the FDA in 2009. Supernus plans to launch Qelbree in the U.S. in the second quarter, during back-to-school season for many families.

Formerly known as SPN-812, Qelbree is a serotonin norepinephrine modulating agent. Its active ingredient, viloxazine hydrochloride, was previously marketed as an antidepressant in Europe. Qelbree comes in a capsule that can be sprinkled.

The data supporting Qelbree comes from a development program comprising four Phase III clinical trials that studied more than 1,000 patients aged 6 to 17 years. In March 2019, Supernus presented Phase III data demonstrating that Qelbree’s “400-mg dose had bested placebo at reducing the ADHD symptoms in adolescents, while a 600-mg dose ‘narrowly missed’ statistical significance. Notably, Supernus said that the 400-mg dose charted statistically significant onset of action at the second-week mark, which continued until the study ended at week 7.”

“Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research,” said Jack A. Khattar, president and chief executive officer of Supernus, in a prepared statement.