FDA Approves Qelbree (viloxazine) as First New Children's ADHD Drug in 10 Years

TUESDAY, April 6, 2021 -- The first new drug developed in over a decade for children with attention deficit hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration.

Qelbree, also known as viloxazine, comes in a capsule that is taken daily, and is not a stimulant. This makes it harder to abuse than older ADHD drugs, nearly all of which contain the stimulants amphetamine or methylphenidate.

Experts say the drug may appeal to parents who don't want to give their child stimulants.

It also could be an option for kids who already have substance abuse problems, dislike the side effects of stimulants or need additional therapy, Dr. David Goodman told the Associated Press. He's an assistant professor of psychiatry at Johns Hopkins School of Medicine in Baltimore.

Goodman said most ADHD patients are prescribed long-acting stimulants, which are harder to abuse to get a high than the original, fast-acting versions of these drugs. Developed by Supernus Pharmaceuticals of Rockville, Md., Qelbree carries a warning about the potential for suicidal thoughts and behavior, which occurred in fewer than 1% of volunteers in studies of the drug, the AP said.

Supernus wouldn't disclose the drug's list price, but it's sure to be higher than the many cheap generic ADHD pills on the market today, the AP said.

ADHD affects about 6 million American children and adolescents, according to the U.S. Centers for Disease Control and Prevention. For many, problems include trouble paying attention and completing tasks, fidgeting and impulsiveness.

In a late-stage study funded by Supernus, 477 children aged 6 to 11 took the drug for six weeks. Inattention and hyperactivity symptoms were reduced by about 50% compared to the placebo group, the AP reported. Qelbree helped reduce symptoms in some study volunteers within a week. Common side effects included sleepiness, lethargy, decreased appetite and headache.

Supernus is in late-stage testing of Qelbree for adults with ADHD, the AP said. It's in a much smaller group than children, but that market is growing because few adults currently take ADHD medicines.

Viloxazine was sold as an antidepressant in Europe for several decades, but was never approved by the FDA, the AP reported. The maker ended sales for business reasons nearly two decades ago, as popular pills such as Zoloft and Prozac came to dominate the market.

Posted: April 2021