FDA approves new ADHD medication for children

The Food and Drug Administration has approved a drug for the treatment of ADHD in children for the first time in more than a decade, reports AP.

Why it matters: The drug, Qelbree, is not a controlled drug or a stimulant, which means it is harder to abuse than drugs already on the market.

What they say: Experts believe the drug provides an opportunity for parents who want to avoid giving their child stimulants, and as a better option for children with substance abuse problems, according to AP.

  • In Supernus’ late-stage study, hyperactivity and inattention symptoms were reduced by approximately 50% in 477 children aged 6-11 years compared with 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,” the drug’s manufacturer, Supernus Pharmaceuticals, said in a press release Friday.

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