FDA approves new ADHD drug for children
The Food and Drug Administration has approved a drug to treat ADHD in children for the first time in over a decade, AP reports.
Why it matters: The drug, Qelbree, is not a controlled substance or a stimulant, meaning it is harder to abuse than drugs already on the market.
What they're saying: Experts say the drug presents an opportunity for parents who want to avoid giving their child stimulants, and as a better option for kids with substance abuse problems, per AP.
- In Supernus' late-stage study, hyperactivity and inattention symptoms in 477 children ages 6-11 were reduced by about 50% compared to the placebo group. Lethargy, headaches, and decreased appetite were common side effects.
- Qelbree "may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed," Supernus Pharmaceuticals, the manufacturer of the drug, said in a Friday press release.