FDA Approves Prescription-Only Video Game For Children With ADHD

The Food and Drug Administration announced Monday that it has approved EndeavorRx, a prescription-only video game designed to treat attention deficit hyperactivity disorder (ADHD).

The game, intended for children ages 8 to 12, is “the first game-based therapeutic granted marketing authorization by the FDA for any type of condition,” according to the agency’s press release. 

Produced by Akili Interactive Labs, a company that uses the tagline “It’s time to play your medicine,” EndeavorRx was tested in five studies focusing on more than 600 children diagnosed with ADHD. The results, published in The Lancet Digital Health journal, found that children who played the game for 25 minutes per day, five days per week, over a period of four weeks showed a noticeable increase in attention span.

The report in The Lancet came with a caveat: The studies were “not sufficient to suggest that [the game] should be used as an alternative to established and recommended treatments for ADHD.”

Players of EndeavorRx complete missions by steering a small alien avatar along a track, collecting specifically colored critters along the way.

According to documentation provided by Akili Interactive Labs, the game was “designed to challenge a child’s attention during treatment, requiring attention and focus on multiple tasks at the same time.” In order to prevent overuse, the company noted, players are allowed to complete only five of the game’s missions per day ― with one “daily treatment” lasting an estimated 25 to 30 minutes and intended to be repeated five days a week over a one-month treatment cycle.

Intended for use on iPhones and iPads, the game is not immediately downloadable but there is a waitlist on the company’s website. The site also points out that EndeavorRx is part of a larger ADHD treatment program that includes ADHD Insight, a behavior tracking app for parents, and Akili Assist, a company resource hotline. 

In an Akili press release from April, Raun Melmed, a Scottsdale, Arizona-based developmental pediatrician specializing in the treatment of ADHD and autism, praised the game’s “positive impact” in clinical trials.

“My hope is that this intervention could play a valuable role as part of an integrated and comprehensive treatment approach for children with attentional challenges,” Melmed said.