Doctors can prescribe a video game for kids with ADHD after landmark FDA decision
After nearly a decade of research, a video game can be prescribed and advertised as medicine to help children improve attention function for the first time in history, the U.S. Food & Drug Administration announced Monday.
The move challenges the status quo of medicine as it offers a non-drug treatment for children ages 8 to 12 struggling with attention deficit hyperactivity disorder, the FDA said in a statement.
Akili, a prescription digital medicine company, developed the game called EndeavorRx that involves traveling through rivers and galaxies, among other simulations, to collect targets along the way.
“It’s time to play your medicine,” the company’s website reads.
“We’re proud to make history today with FDA’s decision,” Eddie Martucci, chief executive officer of Akili, wrote in a statement. “With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment.
“Families are looking for new ways to help their children with ADHD. With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues,” Martucci continued.
About 4 million children between the ages of 6 and 11 have ADHD and experience symptoms such as difficulty staying focused and controlling behavior, and also exhibiting impulses “that interfere with functioning or development,” the FDA said.
That’s why the game was designed to “directly target and activate neural systems through presentation of sensory stimuli and motor challenges to improve cognitive functioning,” Akili said.
It’s also intended to be part of a therapeutic program including medications, educational programs or clinician-directed therapy, the FDA added.
Five studies observing more than 600 children revealed that after four weeks of playing the video game, one-third of participants no longer showed a “measurable” lack of attention on at least one type of attention test, according to Akili.
After one month, about half of the parents saw a “clinically meaningful change in their child’s day-to-day impairments,” according to the company. On month two, the number of parents expressing attention improvements in their children grew to 68%, the company said.
One of the studies was published in February in The Lancet Digital Health journal.
The FDA said children did not experience any negative reactions, but the most common adverse events included “frustration, headache, dizziness, emotional reaction and aggression.”
The video game is expected to be available with a prescription to families soon, Akili said.
