Federal regulators have approved a new medication to help manage attention deficit hyperactivity disorder (ADHD).<\/p>\n
SIMTRIYO is a daily tablet authorized for adults and children 6 years and older who weigh at least 44 pounds.<\/p>\n
Experts say the new medication could be an important additional asset in the treatment and management of ADHD.<\/p>\n
A new medication to help treat attention deficit hyperactivity disorder (ADHD) will be available later this year.<\/p>\n
Otsuka Pharmaceutical has received\u00a0approval<\/a>\u00a0from the Food and Drug Administration (FDA) for SIMTRIYO, a daily extended-relief tablet that contains the active ingredient centanafadine.<\/p>\n The new medication is approved for use in adults and children 6 years and older who weigh at least 44 pounds.<\/p>\n Otsuka officials say their drug is the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) to treat ADHD.<\/p>\n SIMTRIYO \u201cintroduces a new treatment approach for patients and healthcare professionals managing this complex and highly individualized condition.\u201d<\/p>\n \u201cThe approval of SIMTRIYO\u00a0marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,\u201d said\u00a0John Kraus<\/a>, MD, executive vice president and chief medical officer for Otsuka, in a\u00a0statement<\/a>.<\/p>\n 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.<\/p>\n They expect SIMTRIYO to be available as a prescription medication later this year.<\/p>\n Daniel Ganjian<\/a>, MD, a pediatrician at Providence Saint John\u2019s Health Center in California, said he believes the new medication could potentially have a big impact.<\/p>\n \u201cI think it will help, especially for patients have who have tried other medications without much success,\u201d Ganjian told Healthline. \u201cIt\u2019s adding more tools to our arsenal.\u201d<\/p>\n New ADHD drug shows significant improvement in symptoms<\/p>\n 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.<\/p>\n They say the trials showed that people using SIMTRIYO \u201cdemonstrated statistically significant and clinically meaningful improvements in ADHD symptoms\u201d compared to people who were given a placebo.<\/p>\n Two of the trials<\/a>\u00a0involved adults with ADHD between the ages of 18 and 55 who were given 200 milligrams (mg) or 400 mg of centanafadine.<\/p>\n Another\u00a0trial<\/a>\u00a0consisted of 459 adolescents between the ages of 13 and 17 who had a primary diagnosis of ADHD. A fourth\u00a0trial<\/a>\u00a0involved 480 children between the ages of 6 and 12 with a primary diagnosis of ADHD.<\/p>\n Otsuka also reported that a recently completed\u00a0phase 3b study<\/a>\u00a0involving adults with ADHD and comorbid anxiety showed that centanafadine \u201cdemonstrated statistically significant improvements in ADHD symptoms\u201d when compared with a placebo group.<\/p>\n 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.<\/p>\n SIMTRIYO does carry a\u00a0boxed label warning<\/a>\u00a0for a risk of suicidal ideation and behaviors in pediatric patients as well as for the potential for abuse, misuse, and addiction.<\/p>\n Ganjian said he thinks SIMTRIYO will be effective because it works on three neurotransmitters instead of just one or two.<\/p>\n He said his biggest concern is the boxed label warning, something he will \u201ckeep an eye on.\u201d<\/p>\n Ganjian said he plans to initially continue using the current medications for ADHD and then prescribe SIMTRIYO if those don\u2019t work. However, he said SIMTRIYO could become a primary medication after it\u2019s been on the market and has proven to be successful.<\/p>\n \u201cOnce it\u2019s mainstream, I\u2019ll look forward to using it more,\u201d he said.<\/p>\n Max Wiznitzer<\/a>, 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<\/a>), said he also plans to use SIMTRIYO as a backup treatment for people who aren\u2019t seeing benefits from current medications.<\/p>\n 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.<\/p>\n \u201cIt\u2019s good to have another alternative,\u201d he told Healthline.<\/p>\n ADHD prevalence and treatment options<\/p>\n The Centers for Disease Control and Prevention (CDC)\u00a0estimates<\/a>\u00a0that 7 million children ages 3 to 17 in the United States have a diagnosis of ADHD.<\/p>\n In addition, the CDC\u00a0reports<\/a>\u00a0that 15 million adults in the United States have an ADHD diagnosis. More than half of these cases (nearly 56%) were diagnosed in adults.<\/p>\n ADHD<\/a>\u00a0is a condition in which a person has difficulty focusing their attention on a single task or sitting still for long periods of time.<\/p>\n This lack of focus can have a significant effect on school, work, relationships, and home life.<\/p>\n Some common symptoms of ADHD are:<\/p>\n lack of ability to focus on tasks<\/p>\n forgetfulness in completing tasks<\/p>\n having difficulty sitting still<\/p>\n interrupting people while they\u2019re talking<\/p>\n ADHD has been classified into three types: predominantly inattentive, predominantly hyperactivity-impulsive, and a combination of both.<\/p>\n The exact causes of ADHD aren\u2019t fully understood, although experts say the condition has neurological origins. Genetics may also play a role.<\/p>\n Treatment for ADHD generally involves therapy, medication, or both.<\/p>\n Behavioral therapy<\/a>\u00a0can help a person with ADHD learn how to monitor and manage behavior.<\/p>\n Medication<\/a>\u00a0can also be helpful for people living with ADHD. The two main types of medications used to treat ADHD are stimulants and nonstimulants.<\/p>\n Stimulant medications include\u00a0methylphenidate<\/a>\u00a0(Ritalin) and amphetamine-based stimulants such as\u00a0Adderall<\/a>.<\/p>\n