A new drug for ADHD: Does it really change the rules of the game?

Just before the start of the school year, as more parents are re-examining treatment options for Attention Deficit Hyperactivity Disorder (ADHD), a new drug has been approved in the United States that is generating significant interest in the medical community. It is Simtriyo (centanafadine), which was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of children aged 6 and older, adolescents, and adults suffering from ADHD.

The uniqueness of the drug lies in its mechanism of action: unlike most existing drugs, which act primarily on two neurotransmitters, dopamine and norepinephrine, Simtriyo also affects serotonin, making it the first approved drug in the NDSRI class.

What did the studies show?

The FDA approval was based on four Phase 3 studies, which found that the drug significantly reduced ADHD symptoms compared to a placebo. According to the company's data, some patients began to show improvement as early as the first week of treatment. However, as with any new drug, side effects were reported. Among children and adolescents, the most common were decreased appetite, abdominal pain, nausea, headaches, and rash. Adults also reported insomnia, dry mouth, and diarrhea.

Is this a breakthrough?

Despite the enthusiasm surrounding the approval, experts in the field of ADHD are calling for caution. According to them, regulatory approval is an important step, but it does not necessarily mean that the new drug is superior to older drugs that have decades of clinical experience. Experts say that years of cumulative experience and additional studies will be required to understand whether the new mechanism has a significant advantage in terms of efficacy, safety, or the patients' quality of life. Only after wider use will it be possible to better evaluate its long-term effects and safety profile.

And what about Israel?

As of now, Simtriyo is not registered or approved for use in Israel. Even after FDA approval, new drugs are required to undergo additional regulatory procedures in each country before they can be marketed locally.

The experts' message

Experts estimate that the entry of a new drug into the market is positive news, as it expands treatment options for patients who do not respond well to existing drugs or suffer from side effects. However, they emphasize that at this stage, there is no reason to rush to label Simtriyo a "miracle drug." According to them, ADHD treatment should continue to be tailored individually to each patient, combining professional diagnosis, medical monitoring, and, if necessary, emotional, behavioral, or educational therapy.

"The decision to switch to a new treatment should be based on solid medical evidence and cumulative clinical experience, not just on the fact that it is a new drug," experts emphasize.