FDA approves first prescription video game to treat ADHD in children

For the first time in history, “go take your medicine” now can mean, “go play a video game”.

This week, the the U.S. Food and Drug Administration (FDA) permitted, for the first time, marketing of an iPhone and iPad game to improve attention function in children with attention deficit hyperactivity disorder (ADHD).

Akili Interactive’s EndeavorRX is the result of seven years of clinical trials that studied over 600 children to figure out whether a video game could actually make a difference. The result is a treatment option that doesn’t include prescribing a traditional drug. As Akili calls it, “It’s time to play your medicine.”

EndeavorRx’s 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. That’s doctor-speak for: the game helps a brain that works in its own way function better.

“We’re proud to make history today with FDA’s decision,” Akili CEO Eddie Martucci, Ph.D., said. “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 the decision by the 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.”

The target patient audience is ages eight to 12 years old, with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. In studies, 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” after playing the game, which involves dodging obstacles and collecting targets — a pretty standard video game — for 25 minutes a day, five days a week for four days.

The game first became available as a treatment in April under FDA’s enforcement discretion policy for use as a treatment during the COVID-19 pandemic.

The most common adverse events observed with EndeavorRx were, according to the FDA’s study: frustration, headache, dizziness, emotional reaction, and aggression.

“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 Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.