ROCKVILLE, Md. — The U.S. Food and Drug Administration on Friday approved the first new drug in more than 10 years for the treatment of attention deficit hyperactivity disorder, or ADHD, in pediatric patients ages 6-17.
ADHD affects an estimated 6 million American children and adolescents and is typically associated with inattention, hyperactivity and impulsivity that often results in fidgety patients who experience difficulty staying focused and completing tasks, The Associated Press reported.
The new drug, viloxazine extended-release capsules to be prescribed under the brand name Qelbree, was created by Rockville, Maryland-based Supernus Pharmaceuticals.
“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” Supernus Pharmaceuticals President and CEO Jack Khattar said in a prepared statement.
“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,” Khattar added.
Qelbree is a once-daily, rapid and extended release “sprinkleable” capsule, Psychiatric Times reported, noting the medication’s approval was supported by data from four third-phase clinical trials that studied more than 1,000 pediatric patients whose ages ranged from 6 to 17 years.
Dr. Andrew Cutler, a clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer at the Neuroscience Education Institute, told the publication that ADHD is one of the “most common” mental health issues reported in the United States.
“The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel, once-a-day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD,” Cutler said.
Because Qelbree is neither a stimulant nor a controlled substance, unlike nearly all other ADHD medications, experts are hopeful the new treatment will be more difficult to abuse than older drugs, such as Ritalin, the AP reported.
The new drug does carry a warning of the potential for suicidal thoughts and behavior, but the adverse effects were reported in fewer than 1% of clinical trial volunteers, both outlets reported.
--The Associated Press contributed to this report.