The American regulatory agency has just authorized viloxazine, a molecule usually used against depression, to treat children’s attention deficit disorder (ADHD).
- Viloxazine is not a stimulant but blocks the absorption of norepinephrine, an excitatory brain chemical.
- A phase 3 clinical study showed that symptoms of inattention and hyperactivity were reduced by around 50% in children, sometimes after as little as a week.
- Reported side effects are drowsiness, lethargy, decreased appetite and headache.
This is a first for ten years. A new molecule has been authorized last Friday in the United States by the FDA (Food Drug and Administration), the US regulatory agency, to treat children’s attention deficit disorder (ADHD). It is viloxazine, a molecule usually used against depression, and sold under the name of its drug, Qelbree. This was sold for many years in Europe to treat major depressive episodes but was never approved by the FDA and was withdrawn from the world market in 2005.
Reduced symptoms after a week
This molecule, which comes in the form of a capsule to be taken daily, is not a stimulant or controlled substance, unlike almost all other ADHD medications. Pharmacologically, it is a so-called non-tricyclic antidepressant, a norepinephrine reuptake inhibitor, which means that it blocks the absorption of norepinephrine, an excitatory chemical in the brain. “It could also be an option for children who have addiction issues, dislike the side effects of stimulants, or need additional therapy.”, estimated Dr. David W. Goodman, and assistant professor of psychiatry at the Johns Hopkins School of Medicine, at theAssociated Press, the US news agency. The Qelbree carries a warning about the risk of suicidal thoughts and behaviors, which appeared in less than 1% of volunteers who took part in studies of the drug.
The phase 3 clinical trial, published on July 25, 2020 in the journal Clinical Therapeutics, showed that symptoms of inattention and hyperactivity were reduced by approximately 50%. This brought together 477 children aged 6 to 11 who took the drug for six weeks. In some of these children the symptoms were reduced after only one week. Reported side effects are drowsiness, lethargy, decreased appetite and headache. Further tests are currently underway to study the effects of this drug on adults.
One in ten young Americans concerned
According to a French study published in October 2020, only 0.3% of French children suffer from attention deficit disorder with or without hyperactivity (ADHD), a figure far removed from that of the United States, where 9% of young people would be victims of this health problem, described by certain specialists as a real “epidemic”.
“Despite decades of research, there is currently no biological marker or test to identify or confirm the diagnosis of hyperactivity. The prevalence of hyperactivity/ADHD is therefore the subject of intense debate at the international level”, wrote last year Sébastien Ponnou, author of the study, psychoanalyst and lecturer at the University of Rouen-Normandy.“In France, the only study available points to an ADHD prevalence rate of 3.5 to 5.6% of children aged 6 to 12. The authors also estimate that 3.48% of 6 to 12 year olds are treated with psychostimulant. Our article is based on the data of the Health insurance to discuss these results”, explained the specialist.
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