FDA approves first new children’s ADHD drug in over a decade

The Food and Drug Administration (FDA) approved the first new medication to treat ADHD in children in over a decade last week.

The FDA approved Qelbree for use in children with ADHD aged 6 to 17 on Friday, the Associated Press reports. It comes as a capsule and is meant to be taken daily.

According to the AP, Qelbree, unlike other ADHD drugs, is not a stimulant. That makes it less addictive and less likely to be abused than other medicines that contain either amphetamine or methylphenidate. Qelbree, also known as viloxazine, comes with a warning that it may cause suicidal thoughts and behavior, which was observed in less than 1 percent of volunteers in studies.

The drug’s developer, Supernus Pharmaceuticals of Rockville, Md., has not disclosed what the price of Qelbree will be, though it will likely be more expensive than generic ADHD medications.

Side effects include sleepiness, lethargy, decreased appetite and headache, according to the AP.

In a study funded by Supernus, 477 children aged 6 to 11 took Qelbree for six weeks and symptoms of inattention and hyperactivity were found to decrease by 50 percent when compared to the placebo group, the AP reports. The drug is also in late-stage testing for adults.

Dr. David W. Goodman, professor of psychiatry at Johns Hopkins School of Medicine, told the AP that the new drug may appeal to children and young people who struggle with substance abuse issues and do not want the side effects that come with stimulants prescribed for ADHD.

Viloxazine was sold in Europe as an antidepressant for several decades, the AP notes, but was abandoned when newer drugs like Prozac and Zoloft entered the market. It had never been approved in the U.S. before this recent decision.