- Federal regulators have approved a new medication to help manage attention deficit hyperactivity disorder (ADHD).
- SIMTRIYO is a daily tablet authorized for adults and children 6 years and older who weigh at least 44 pounds.
- Experts say the new medication could be an important additional asset in the treatment and management of ADHD.
A new medication to help treat attention deficit hyperactivity disorder (ADHD) will be available later this year.
Otsuka Pharmaceutical has received approval from the Food and Drug Administration (FDA) for SIMTRIYO, a daily extended-relief tablet that contains the active ingredient centanafadine.
The new medication is approved for use in adults and children 6 years and older who weigh at least 44 pounds.
Otsuka officials say their drug is the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) to treat ADHD.
SIMTRIYO “introduces a new treatment approach for patients and healthcare professionals managing this complex and highly individualized condition.”
“The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,” said John Kraus, MD, executive vice president and chief medical officer for Otsuka, in a statement.
The company said SIMTRIYO still needs to go through hearings with the federal Drug Enforcement Administration (DEA) to determine which scheduling classification the drug will be assigned.
They expect SIMTRIYO to be available as a prescription medication later this year.
Daniel Ganjian, MD, a pediatrician at Providence Saint John’s Health Center in California, said he believes the new medication could potentially have a big impact.
“I think it will help, especially for patients have who have tried other medications without much success,” Ganjian told Healthline. “It’s adding more tools to our arsenal.”
New ADHD drug shows significant improvement in symptoms
Otsuka officials say the effectiveness and safety of SIMTRIYO have been supported by results from four different phase 3 clinical trials that involved adults, adolescents, and children with ADHD.
They say the trials showed that people using SIMTRIYO “demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms” compared to people who were given a placebo.
Two of the trials involved adults with ADHD between the ages of 18 and 55 who were given 200 milligrams (mg) or 400 mg of centanafadine.
Another trial consisted of 459 adolescents between the ages of 13 and 17 who had a primary diagnosis of ADHD. A fourth trial involved 480 children between the ages of 6 and 12 with a primary diagnosis of ADHD.
Otsuka also reported that a recently completed phase 3b study involving adults with ADHD and comorbid anxiety showed that centanafadine “demonstrated statistically significant improvements in ADHD symptoms” when compared with a placebo group.
The most common side effects reported during these trials were decreased appetite, nausea, rash, headache, and abdominal pain in children and adolescents as well as headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.
SIMTRIYO does carry a boxed label warning for a risk of suicidal ideation and behaviors in pediatric patients as well as for the potential for abuse, misuse, and addiction.
Ganjian said he thinks SIMTRIYO will be effective because it works on three neurotransmitters instead of just one or two.
He said his biggest concern is the boxed label warning, something he will “keep an eye on.”
Ganjian said he plans to initially continue using the current medications for ADHD and then prescribe SIMTRIYO if those don’t work. However, he said SIMTRIYO could become a primary medication after it’s been on the market and has proven to be successful.
“Once it’s mainstream, I’ll look forward to using it more,” he said.
Max Wiznitzer, MD, a professor of pediatrics and neurology at Case Western Reserve University in Ohio and the co-chair of the Professional Advisory Board for the organization Children and Adults with ADHD (CHADD), said he also plans to use SIMTRIYO as a backup treatment for people who aren’t seeing benefits from current medications.
Wiznitzer said he needs more evidence that SIMTRIYO is more effective than stimulant-based medications before prescribing it more often, but he is glad to have it available.
“It’s good to have another alternative,” he told Healthline.
ADHD prevalence and treatment options
The Centers for Disease Control and Prevention (CDC) estimates that 7 million children ages 3 to 17 in the United States have a diagnosis of ADHD.
In addition, the CDC reports that 15 million adults in the United States have an ADHD diagnosis. More than half of these cases (nearly 56%) were diagnosed in adults.
ADHD is a condition in which a person has difficulty focusing their attention on a single task or sitting still for long periods of time.
This lack of focus can have a significant effect on school, work, relationships, and home life.
Some common symptoms of ADHD are:
- lack of ability to focus on tasks
- forgetfulness in completing tasks
- being easily distracted
- having difficulty sitting still
- interrupting people while they’re talking
ADHD has been classified into three types: predominantly inattentive, predominantly hyperactivity-impulsive, and a combination of both.
The exact causes of ADHD aren’t fully understood, although experts say the condition has neurological origins. Genetics may also play a role.
Treatment for ADHD generally involves therapy, medication, or both.
Behavioral therapy can help a person with ADHD learn how to monitor and manage behavior.
Medication can also be helpful for people living with ADHD. The two main types of medications used to treat ADHD are stimulants and nonstimulants.
Stimulant medications include methylphenidate (Ritalin) and amphetamine-based stimulants such as Adderall.
Nonstimulant medications include atomoxetine (Strattera).
ADHD treatment is often individualized
Ganjian said the most important thing for adults and children with ADHD to know is that the condition should not be ignored.
He said ADHD can hamper a person’s daily life, lower their self-esteem, hinder personal relationships, and impair their ability to do work.
“I let patients know that this condition is highly treatable and the treatment for each person is different,” he said.
Ganjian tells parents that behavioral therapy, organization skills, quality sleep, and exercise are all important components of an ADHD treatment plan for children.
He also says that parents should be involved in their child’s school, so that things like a quiet place to do homework, more time to take tests, and perhaps a smaller class size can be accommodated.
“I let them know that we can work together. That this is a team approach,” he said.
Wiznitzer agreed that patients need to know the impacts ADHD can have on a person’s life as well as their family members, co-workers, friends, and others in their circle.
“It affects all aspects of your life and those who are around you,” he said.
Wiznitzer said it’s important for patients, especially adults who have been living for years with ADHD, to know that medications can lessen symptoms, but it’s behavioral and other therapies that can change behavior.
“I always say that medication can get you to the starting line, but you still have to run the race,” he said.
FDA Approves ‘First-in-Class’ NDSRI for ADHD in Adults and Children
Source: Pinoy Lang Sakalam
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