U.S. regulators have approved the first new drug in more than a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity.
The Food and Drug Administration late Friday approved Qelbree (KELL’-bree) to treat attention deficit hyperactivity disorder in children ages 6-17. It is presented as a capsule that is taken daily.
Unlike almost all other anti-ADHD medications, Qelbree is not a stimulant or a controlled substance, making it more difficult to abuse than older medications. This has been a problem with previous ADHD treatments such as Ritalin, which contain almost all amphetamine or methylphenidate stimulants.
Qelbree, developed by Supernus Pharmaceuticals in Rockville, Maryland, presents a warning of the possibility of suicidal behaviors and thoughts, which occurred in less than 1% of volunteers in drug studies.
Supernus would not reveal the list price of the drug, but it will certainly be higher than the many generic ADHD pills.
ADHD affects nearly 6 million American children and adolescents. For many, problems include problems paying attention and completing tasks, restlessness, and impulsivity.
Experts say the drug may appeal to parents who do not want to give stimulants to their children.
It could also be an option for children with substance abuse problems, who don’t like the side effects of stimulants or who need additional therapy, said Dr. David W. Goodman, director of Suburban Psychiatric Associates near Baltimore and assistant professor of psychiatry at the Johns Hopkins School of Medicine.
Goodman said most ADHD patients taking medications are currently prescribed long-acting stimulants, which are harder to abuse to get a maximum than the original fast-acting versions.
In a key final-phase study funded by Supernus, 477 children ages 6 to 11 took the drug for six weeks. Attention symptoms and hyperactivity were reduced by about 50% compared with the placebo group. Qelbree, also known as viloxazine, helped reduce symptoms in some study volunteers within a week. Common side effects include drowsiness, lethargy, decreased appetite, and headache.
Supernus is in final-stage testing for adults with ADHD. It is a much smaller group than children, but this market is growing because there are currently few adults taking anti-ADHD medications.
Viloxazine was sold as an antidepressant in Europe for several decades, but was never approved by the FDA. The manufacturer ended sales for commercial reasons almost two decades ago, as popular tablets like Zoloft and Prozac came to dominate the market.
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Follow Linda A. Johnson on Twitter: @LindaJ_onPharma
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