A medicine for attention deficit hyperactivity disorder (ADHD) is about to increase the options available to patients and physicians. The U.S. Food and Drug Administration (FDA) has approved SIMTRIYO (centanafadine), the first norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) for ADHD.
The once-daily extended-release pill is approved for teenagers and adults as well as children aged six years and old with a minimal weight of forty-four extra pounds.
Though doctors and families are welcoming the approval of SIMTRIYO with excitement, it has also raised several practical questions. What makes this medicine unique from other ADHD medicines? Who is going to profit from it the most? So, can it be given to children with ADHD and have autism? And when can one expect it in India? Dr. K K Jindal, Director – Neurology at the CK Birla Hospital®, Delhi, answers some of the most common questions parents may have.
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Q) The FDA has approved a new non-stimulant medicine for ADHD. How is it different from the ADHD medicines already available?
Answer) The newly approved Centanafadine has a new treatment option for the disorder named Attention-Deficit/Hyperactivity Disorder, and it’s also said to be the first-known drug that belongs to the class of norepinephrine-dopamine-serotonin reuptake inhibitors (NDSRIs) for the treatment of ADHD, which tells that Centanafadine’s action involves three different neurotransmitter systems.
Since conventional stimulant drugs such as methylphenidate and amphetamines have only two neurotransmitter targets that work on the dopamine and norepinephrine system, Centanafadine is different since it also acts on serotonin, a neurotransmitter that is important in mood regulation and executive functions. Unlike the existing non-stimulant drugs, such as atomoxetine, guanfacine, and clonidine, which act differently, centanafadine expands the available treatment options for ADHD. Nevertheless, there is not enough evidence to claim that the new drug will replace any existing treatment for the condition, and it may be better for ADHD until more evidence is obtained.
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Q) Who is this new medicine meant for? Could it help children and adults who don’t benefit from current ADHD treatments?
Answer) The FDA has given the green light to centanafadine for the use of children over six years old and weighing a minimum of 20 kg, as well as adolescents and adults with Attention Deficit Hyperactivity Disorder. This drug may be especially helpful for those not able to control their symptoms with existing medications, who suffer from troublesome side effects of stimulant drugs or non-stimulant techniques, or who need an alternative in this respect; ADHD patients, in general, require personalized treatment approaches.
Different people suffer from ADHD differently; having an additional medicine in the arsenal gives doctors more options to choose from. At the same time, it must be understood that no remedy can work for everyone the same way, so every treatment must be chosen based on a thorough assessment and continuous monitoring.
Q) Does this new medicine have fewer side effects, such as sleep problems, loss of appetite, or mood changes?
Answer) According to the evidence presented from Phase 3 clinical studies, centanafadine can be considered to be relatively safe despite potential adverse effects. The most frequently observed side effects of this drug include diminished appetite, nausea, headache, tiredness, pain in the stomach, skin rash, and somnolence.
Nevertheless, there are no convincing results showing that centanafadine causes fewer sleep disturbances, a reduction in appetite, or psychological effects than existing medications prescribed for treating ADHD. Its long-term safety and efficiency can only be confirmed with successive usage of the drug in reality and monitoring its activity after market application. It is important for parents to keep in mind that each child reacts differently to any treatment and, therefore, an individual approach is needed for every patient.
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Q) Could this new treatment also help people who have both ADHD and autism, or is it only for ADHD?
Answer) Centanafadine is currently only authorized for therapeutic usage in the case of Attention Deficit Hyperactivity Disorder (ADHD). Various children and adults suffering from autism spectrum disorder (ASD) also have ADHD. Thus, if they meet the requirements for diagnosis of this disorder, medications of this kind can be given under the supervision of a developmental specialist, children’s psychiatrist, or neurologist. However, there is no proof yet of centanafadine having a positive impact on such symptoms of autism, such as difficulties with social interaction, limited interests, or repetitive behaviours. So, studies aimed at addressing this confusion need to be conducted.
Q) When do you think this medicine could become available in India, and what should parents know before getting excited about it?
Answer) There is currently no official timeline for the launch date of centanafadine in India. Although the approval by the US FDA is an encouraging development, medications typically go through a separate approval process in other countries. Parents must understand that this is a ‘good addition’ to the whole ADHD treatment options available, rather than a ‘breakthrough’.
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ADHD treatment is based on a comprehensive treatment strategy combining behavioural therapy, educational assistance, parents’ training, and medication if clinically warranted. All decisions concerning medications have to be made in consultation with the child psychiatrist or developmental practitioner who specializes in ADHD management.
Q) What do parents need to know before starting these medicines? Can medicines cure ADHD and autism symptoms?
Answer) It is important to confirm the diagnosis before initiating any ADHD medication and to verify that the child’s symptoms are causing significant functional impairment. An appropriate pre-treatment assessment should involve measuring the child’s height, weight, blood pressure, heart rate, sleep patterns, and appetite. Furthermore, ongoing checks must occur to monitor both the response to treatment and side effects that may arise.
Parents need to keep in mind that medications do not represent a cure for ADHD. They only aid with improving attention, reducing hyperactivity and impulsivity, and increasing the quality of life if a child is taking them. However, the most successful outcomes of the treatment are achieved by using medications alongside behavioural strategies, educational adaptations, and family help. Also, medications do not represent a cure for autism spectrum disorder. Nevertheless, they can control related symptoms like hyperactivity, violence, anxiety, irritability, and sleep disorders, but do not deal with autism itself.
