Over 1 in 10 children in the US aged between 5 and 17 have been diagnosed with attention deficit hyperactivity disorder (ADHD). Now, the Food and Drug Administration has approved Qelbree, a new non-stimulant drug for children aged 6 to 17 with the condition.
ADHD is a mental health disorder characterized by hyperactivity and impulsive behaviors. Those with the condition tend to struggle to focus and have difficulty sitting still for long periods of time. There is no known exact cause for the condition, although theories say it may be at least partially genetic and/ or due to multigenerational family stress and disturbed social conditions.
Currently, there are around 30 stimulant medications available to treat ADHD. These include drugs like Adderall and Ritalin, which work by increasing norepinephrine and dopamine levels in their brain by increasing their release and blocking their reuptake.
While effective in improving concentration and executive functioning in some, these drugs nevertheless carry the potential for addiction and misuse. The way they work also means that they could actually worsen mood symptoms by increasing irritability, agitation.
Meanwhile, there are currently just 4 non-stimulants on the market. These drugs work by inhibiting the reuptake of norepinephrine in the brain. Their lesser activity means that they’re not nearly as controlled as stimulants and that they can work for longer periods of time without causing side effects like insomnia and anxiety.
The approval of Qelbree comes after four Phase III clinical trials involving over 1000 pediatric patients. In December 2020, Supernus Pharmaceuticals additionally announced positive results from Phase III trials for the drug in adult patients. As such, the company now plans to submit a supplemental New Drug Application to the FDA for the use of the drug in adults in the second half of 2021.
While Qelbree has been shown to work relatively quickly- within just one or two weeks and has straight-forward dosing, it does not come without possible side effects. In the first few months of usage, some patients reported an increase in suicidal thoughts and actions. The company also advises that Qelbree should not be taken with antidepressants known as monoamine oxidase inhibitors (MAOIs) or certain asthma medications.