US 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 approved Qelbree (KELL’-bree) late Friday for the treatment of attention deficit hyperactivity disorder in children aged 6 to 17 years. It comes as a daily capsule.
Unlike almost all other ADHD drugs, Qelbree is not a stimulant or a controlled substance, making it harder to abuse than older drugs. 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, has a warning about the potential for suicidal thoughts and behaviors, which occurred in less than 1% of volunteers in drug studies.
Supernus would not disclose the list price of the drug, but it is certain to be higher than many cheap generic ADHD pills.
ADHD affects approximately 6 million American children and adolescents. For many, problems include problems paying attention and completing tasks, agitation, and impulsivity.
Experts say the drug can attract parents who do not want to give their child incentives.
It could also be an option for children who have 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 that most patients with ADHD who are currently taking medication are prescribed long-acting stimulants, which are harder to abuse to achieve a higher level than the original, fast-acting versions.
In a key late-stage study funded by Supernus, 477 children between the ages of 6 and 11 took the drug for six weeks. Symptoms of inattention and hyperactivity were reduced by approximately 50% compared to 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 testing the late stage for adults with ADHD. It is a much smaller group than children, but the market is growing because few adults are currently taking ADHD.
Viloxazine has been sold as an antidepressant in Europe for decades, but has never been approved by the FDA. The manufacturer closed sales for business reasons almost two decades ago, as popular pills such as Zoloft and Prozac came to dominate the market.
___
Follow Linda A. Johnson on Twitter: @LindaJ_onPharma
__
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.