FDA approves video game to treat children with ADHD in landmark move
The US Food and Drug Administration (FDA) has approved a game-based digital therapeutic device: a video game to improve attention among children with attention deficit hyperactivity disorder (ADHD). This is the first time that approval has been given by the agency for a prescription treatment delivered through a video game. The prescription-only game-based device, called EndeavorRx, is meant for pediatric patients ages 8 to12 years with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.
The FDA's move is a landmark decision: besides being the first game to be marketed as a therapy for any type of condition, EndeavorRx is the first digital therapeutic meant to improve symptoms associated with ADHD. "Today, the FDA permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD)," said the agency in a statement.
"EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition. The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication and/or educational programs, which further address symptoms of the disorder," it added.
ADHD is a common disorder that begins in childhood. The estimated number of children diagnosed with ADHD in the US includes 388,000 children aged 2-5 years, 4 million in the 6 to 11 age group, and 3 million aged 12-17 years. Boys are more likely to be diagnosed with ADHD than girls, 12.9% compared to 5.6%, says the US Centers for Disease Control and Prevention (CDC). Symptoms of ADHD include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity.
"Many children with ADHD also have other disorders. According to a national 2016 parent survey, 6 in 10 children with ADHD had at least one other mental, emotional, or behavioral disorder. About 5 in 10 children with ADHD had a behavior or conduct problem. About 3 in 10 children with ADHD had anxiety. Other conditions affecting children with ADHD: depression, autism spectrum disorder, and Tourette Syndrome," said the CDC. According to the agency, diagnosis of ADHD should be conducted by a trained healthcare professional and follow an evaluation of symptoms or patterns of symptoms, such as inattention, hyperactivity and impulsivity that interfere with functioning or development.
EndeavorRx has been developed by Boston-based Akili Interactive Labs. "EndeavorRx was reviewed through FDA's de novo pathway and its clearance creates a new class of digital therapeutics. EndeavorRx is designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning," said the company in a statement.
According to the FDA, the "de novo" process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Akili said that the game is easily accessible from home. EndeavorRx can be downloaded from the app store by families on their mobile devices and does not require any additional equipment.
"For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school. Unlike traditional ADHD medications, EndeavorRx is designed to specifically target inattention," said Dr Elysa Marco, cognitive and behavioral child neurologist and clinical executive for neurodevelopmental medicine at Cortica Healthcare.
EndeavorRx was granted clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, academic performance measures and other assessment tools. One of the studies reviewed was a four-week randomized controlled trial of 348 children aged 8-12 years.
The results, published in The Lancet Digital Health, showed EndeavorRx improved objective measures of attention in children with ADHD. After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention. Further, about half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this increased to 68% after the second month of treatment.
Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month. There were no serious adverse events or discontinuations on the trial. Only 12 children in the intervention group and three in the control group experienced any treatment-related adverse events, the most common of which were frustration (five in the intervention group) and headaches (three in the intervention group).
"The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics. The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.