(RxWiki News) The US Food and Drug Administration (FDA) has approved the marketing of the first game-based digital therapeutic device to treat ADHD.
In other words, this new treatment — called EndeavorRx — comes in the form of a video game. This is the first game-based device the FDA has approved to treat any condition.
It’s uniquely designed to challenge a child’s brain by requiring attention and focus on multiple tasks at the same time, according to the FDA. The agency approved it to help improve attention in children between the ages of 8 and 12 who have ADHD.
The game involves an alien avatar that the user must navigate through a course while responding to on-screen prompts.
ADHD stands for attention-deficit hyperactivity disorder. The condition is marked by high levels of activity, difficulty staying focused or paying attention and trouble controlling behavior.
EndeavorRx can be used with clinician-directed therapy, educational programs and/or medications. This game is not a substitute for ADHD medication, noted Akili Interactive, which markets the game.
“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,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release.
According to the FDA, around 4 million US children between 6 and 11 years old have ADHD.
EndeavorRx was studied in several trials involving more than 600 children. These studies looked at whether children’s attention function improved with use of the game.
Available by prescription only, this game requires children to interact with it for 30 minutes per day, five days per week, for one month. After the month is over, another one-month treatment cycle can be started.
No serious adverse events were reported. However, the most common adverse events linked to EndeavorRx were aggression, dizziness, emotional reaction, frustration, headache and nausea.
Marketing authorization of EndeavorRx was granted to Akili Interactive.