The US Food and Drug Administration (FDA) has approved this oral medication for the treatment of ADHD in children from 6 years old, adolescents, and adults, announces the drug manufacturer “Otsuka”.
Read more Created a fuel price map: how is it useful?
“Simtriyo” is the first-in-class drug for ADHD. It inhibits the reuptake of norepinephrine (noradrenaline), dopamine, and serotonin.
According to doctors, for some patients with ADHD, it may be more suitable than commonly prescribed drugs such as stimulant amphetamine and dextroamphetamine.
“New drugs for ADHD are needed because there are still significant gaps in the treatment of this disorder,” says child and adult psychiatrist Dr. Mai Uchida, associate professor of psychiatry at Harvard Medical School in Boston.
Clinical trials demonstrated the safety and efficacy of “Simtriyo”
Clinical trials of “Simtriyo” evaluated the drug’s effects in children, adolescents, and adults. The most recent published trial results were related to adults.
A phase 3 clinical trial studied a 280 mg dose of “Simtriyo,” taken once daily by adults with ADHD and anxiety disorder. It was found that changes in the condition of people taking the drug, compared to the placebo group, were statistically significant after just one week.
The efficacy of “Simtriyo” was also studied involving nearly 500 children and about 450 adolescents. Participants generally reported a reduction in ADHD symptoms, and positive changes were also observed by their caregivers. Most participants tolerated the drug well – less than 8% discontinued the trials due to side effects.
The results of each study varied slightly. They were assessed using the ADHD rating scale ADHD-RS-5 – an 18-item questionnaire used by doctors, parents, and teachers to evaluate ADHD symptoms in children and adolescents.
In the study involving children aged 6–12 years diagnosed with ADHD.
34% of participants taking a high dose of “Simtriyo” had a reduction of 18 or more points on the ADHD-RS-5 scale. In the placebo group, such improvement was achieved by 23% of children. Similar results were obtained in the study of adolescents aged 13–17 years.
Side effects similar to other ADHD medications
Possible side effects of “Simtriyo” identified during clinical trials include:
reduced appetite;
nausea;
headache;
rash.
Most side effects were mild or moderate in severity.
Doctors emphasize that for some patients, currently used ADHD medications are not sufficiently effective or suitable, so “Simtriyo” may become another treatment option.
When taking some stimulant ADHD medications, people may experience poorly tolerated side effects, anxiety, appetite or sleep disturbances, cardiovascular problems. There may also be concerns about misuse or diversion of the drugs to others.
Read more “PZU Lietuva life insurance” is led by Tomasz Frontczak
According to her, “Simtriyo” may also be relevant for patients who have ADHD along with anxiety symptoms.
According to Dr. Neha Sharma, head of child and adolescent psychiatry at Boston’s Tufts Medical Center, this drug may also be beneficial for children who have difficulty gaining weight when taking certain stimulant ADHD medications.
However, the new medication will not be suitable for everyone. “It may be that for some children experiencing anxiety, this drug will cause an overly strong activating effect,” says Dr. N. Sharma. According to her, it is also likely not suitable for children who do not tolerate selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or bupropion.
How does the new medication work?
“Simtriyo” enhances the activity of natural chemical messengers that influence human behavior in the brain, explains Dr. Kelly Johnson-Arbor, a toxicologist at MedStar Health in Washington.
“Stimulant drugs primarily affect dopamine and norepinephrine activity, while non-stimulant preparations usually affect norepinephrine,” she explains. “Centanafadine acts on three different chemical messengers in the brain: dopamine, norepinephrine, and serotonin.”
According to Dr. K. Johnson-Arbor, the unique effect of “Simtriyo” on the serotonin system may be particularly significant.
“There is increasing evidence suggesting that serotonin affects many central nervous system functions, including emotion regulation, attention, and impulsivity,” she says. “Therefore, serotonin-affecting drugs like centanafadine may be beneficial for some patients with ADHD.”
It is currently unclear when “Simtriyo” might reach the European Union – there is no public information about a centanafadine registration application submitted to or under evaluation by the European Medicines Agency.
Prepared based on information from Medical News Today, Everydayhealth, European Medicines Agency
