American 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 OK’d Qelbree (KELL’-bree) last Friday for the treatment of attention deficit hyperactivity disorder in children aged 6 to 17 years. It comes as a capsule that is taken daily.
Unlike almost all other medications for ADHD, 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, almost all containing stimulants amphetamines or methylphenidate.
Qelbree, developed by Supernus Pharmaceuticals of Rockville, Maryland, carries a potential alert for suicidal thoughts and behavior, which occurred in less than 1% of volunteers in the drug studies.
Supernus did not disclose the list price of the drug, but it will certainly be higher than the many cheap generic pills for ADHD.
ADHD affects about 6 million American children and adolescents. For many, problems include difficulty paying attention and completing tasks, restlessness and impulsiveness.
Experts say the drug may appeal to parents who don’t want to give their kids stimulants.
It can also be an option for children who have substance abuse problems, don’t like the side effects of stimulants or need additional therapy, said Dr. David W. Goodman, director of Suburban Psychiatric Associates near Baltimore and an assistant professor of psychiatry at the Johns Hopkins School of Medicine.
Goodman said that most ADHD patients taking medications today are prescribed long-acting stimulants, which are more difficult to abuse to get a cheap one than the original fast-acting versions.
In a major final-stage study funded by Supernus, 477 children aged 6 to 11 years took the drug for six weeks. The symptoms of inattention and hyperactivity were reduced by about 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 the final stages of testing for adults with ADHD. It is a much smaller group than children, but this market is growing because few adults take medication for ADHD.
Viloxazine has been sold as an antidepressant in Europe for several decades, but has never been approved by the FDA. The manufacturer closed sales for commercial reasons almost two decades ago, when popular pills 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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